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This Is A Study Of Bioavailability And Food Effect For Fesoterodine.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01286454
First received: December 3, 2010
Last updated: January 24, 2012
Last verified: January 2012
History of Changes
Results First Received: December 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-availability Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency
Intervention: Drug: fesoterodine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER Single oral dose of fesoterodine 4 milligram (mg) immediate release (IR) beads-in-capsule (BIC) under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated extended release (ER) BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in forth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
Fesoterodine 4 mg 10% ER Fed Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in sixth intervention period. A washout period of approximately 2 weeks was maintained between fifth and sixth intervention period.

Participant Flow for 11 periods

 Period 1:   Part I- First Intervention Period
    Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER     Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet     Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR     Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER     Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER     Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER     Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER     Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet     Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR     Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER     Fesoterodine 4 mg 10% ER Fed  
STARTED     2     2     2     2     2     2     2     2     2     2     0  
COMPLETED     2     2     2     2     2     2     2     2     2     2     0  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0  

Period 2:   Washout Period (At Least 3 Days)
    Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER     Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet     Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR     Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER     Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER     Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER     Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER     Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet     Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR     Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER     Fesoterodine 4 mg 10% ER Fed  
STARTED     2     2     2     2     2     2     2     2     2     2     0  
COMPLETED     2     2     2     2     2     2     2     2     2     2     0  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0  

Period 3:   Second Intervention Period
    Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER     Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet     Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR     Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER     Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER     Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER     Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER     Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet     Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR     Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER     Fesoterodine 4 mg 10% ER Fed  
STARTED     2     2     2     2     2     2     2     2     2     2     0  
COMPLETED     2     2     2     2     2     2     2     2     2     2     0  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0  

Period 4:   Washout Period (At Least 3 Days)
    Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER     Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet     Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR     Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER     Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER     Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER     Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER     Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet     Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR     Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER     Fesoterodine 4 mg 10% ER Fed  
STARTED     2     2     2     2     2     2     2     2     2     2     0  
COMPLETED     2     2     2     2     2     2     2     2     2     2     0  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0  

Period 5:   Third Intervention Period
    Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER     Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet     Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR     Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER     Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER     Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER     Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER     Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet     Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR     Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER     Fesoterodine 4 mg 10% ER Fed  
STARTED     2     2     2     2     2     2     2     2     2     2     0  
COMPLETED     2     2     2     2     2     2     2     2     2     2     0  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0  

Period 6:   Washout Period (At Least 3 Days)
    Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER     Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet     Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR     Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER     Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER     Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER     Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER     Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet     Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR     Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER     Fesoterodine 4 mg 10% ER Fed  
STARTED     2     2     2     2     2     2     2     2     2     2     0  
COMPLETED     2     2     2     2     2     2     2     2     2     2     0  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0  

Period 7:   Fourth Intervention Period
    Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER     Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet     Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR     Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER     Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER     Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER     Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER     Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet     Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR     Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER     Fesoterodine 4 mg 10% ER Fed  
STARTED     2     2     2     2     2     2     2     2     2     2     0  
COMPLETED     2     2     2     2     2     2     2     2     2     2     0  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0  

Period 8:   Washout Period (At Least 3 Days)
    Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER     Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet     Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR     Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER     Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER     Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER     Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER     Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet     Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR     Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER     Fesoterodine 4 mg 10% ER Fed  
STARTED     2     2     2     2     2     2     2     2     2     2     0  
COMPLETED     2     2     2     2     2     2     2     2     2     2     0  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0  

Period 9:   Fifth Intervention Period
    Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER     Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet     Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR     Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER     Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER     Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER     Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER     Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet     Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR     Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER     Fesoterodine 4 mg 10% ER Fed  
STARTED     2     2     2     2     2     2     2     2     2     2     0  
COMPLETED     2     2     2     2     2     2     2     2     2     2     0  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0  

Period 10:   Washout Period (Approximately 2 Weeks)
    Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER     Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet     Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR     Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER     Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER     Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER     Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER     Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet     Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR     Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER     Fesoterodine 4 mg 10% ER Fed  
STARTED     2     2     2     2     2     2     2     2     2     2     0  
COMPLETED     2     2     2     2     2     2     2     2     2     2     0  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0  

Period 11:   Part II- Sixth Intervention Period
    Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER     Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet     Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR     Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER     Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER     Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER     Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER     Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet     Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR     Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER     Fesoterodine 4 mg 10% ER Fed  
STARTED     0     0     0     0     0     0     0     0     0     0     20  
COMPLETED     0     0     0     0     0     0     0     0     0     0     20  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Entire Study Population Includes groups randomized to receive fesoterodine 4 mg IR-BIC fasted first, 10% ER-BIC fasted first, 15% ER-BIC fasted first, 20% ER-BIC fasted first and ER tablets fasted first.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
 		  20  
Age  
[units: years]
Mean ± Standard Deviation 		  39.5  ± 10.8  
Gender  
[units: participants]
 		 
Female     7  
Male     13  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])   [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose ]

Measure Type Primary
Measure Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])
Measure Description AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time Frame 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.

Reporting Groups
  Description
Fesoterodine 4 mg IR-BIC Fasted Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 10% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 15% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 20% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg ER Tablet Fasted Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 10% ER-BIC Fed Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.

Measured Values
    Fesoterodine 4 mg IR-BIC Fasted     Fesoterodine 4 mg 10% ER-BIC Fasted     Fesoterodine 4 mg 15% ER-BIC Fasted     Fesoterodine 4 mg 20% ER-BIC Fasted     Fesoterodine 4 mg ER Tablet Fasted     Fesoterodine 4 mg 10% ER-BIC Fed  
Number of Participants Analyzed  
[units: participants]
 		  20     20     16     4     20     20  
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])  
[units: ng*hr/mL]
Geometric Mean ± Standard Deviation 		  30.48  ± 11.77     28.24  ± 10.35     19.64  ± 7.58     NA  ± NA [1]   27.40  ± 10.06     32.07  ± 13.24  
[1] Parameter was missing for more than 50 percent of the participants.


Statistical Analysis 1 for Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])
Groups [1] Fesoterodine 4 mg IR-BIC Fasted vs. Fesoterodine 4 mg ER Tablet Fasted
Ratio of Adjusted Means [2] 111.23
90% Confidence Interval ( 102.69 to 120.47 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])
Groups [1] Fesoterodine 4 mg 10% ER-BIC Fasted vs. Fesoterodine 4 mg ER Tablet Fasted
Ratio of Adjusted Means [2] 103.07
90% Confidence Interval ( 95.16 to 111.64 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])
Groups [1] Fesoterodine 4 mg 15% ER-BIC Fasted vs. Fesoterodine 4 mg ER Tablet Fasted
Ratio of Adjusted Means [2] 70.36
90% Confidence Interval ( 64.52 to 76.74 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])
Groups [1] Fesoterodine 4 mg 10% ER-BIC Fasted vs. Fesoterodine 4 mg 10% ER-BIC Fed
Ratio of Adjusted Means [2] 113.55
90% Confidence Interval ( 105.91 to 121.74 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.
[2] Other relevant estimation information:
  No text entered.



2.  Primary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)   [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose ]

Measure Type Primary
Measure Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)
Measure Description Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.
Time Frame 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Reporting Groups
  Description
Fesoterodine 4 mg IR-BIC Fasted Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 10% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 15% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 20% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg ER Tablet Fasted Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 10% ER-BIC Fed Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.

Measured Values
    Fesoterodine 4 mg IR-BIC Fasted     Fesoterodine 4 mg 10% ER-BIC Fasted     Fesoterodine 4 mg 15% ER-BIC Fasted     Fesoterodine 4 mg 20% ER-BIC Fasted     Fesoterodine 4 mg ER Tablet Fasted     Fesoterodine 4 mg 10% ER-BIC Fed  
Number of Participants Analyzed  
[units: participants]
 		  20     20     20     20     20     20  
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)  
[units: ng*hr/mL]
Geometric Mean ± Standard Deviation 		  30.23  ± 11.79     27.79  ± 10.21     17.92  ± 6.95     7.59  ± 3.57     26.80  ± 10.07     31.88  ± 13.24  


Statistical Analysis 1 for Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)
Groups [1] Fesoterodine 4 mg IR-BIC Fasted vs. Fesoterodine 4 mg ER Tablet Fasted
Ratio of Adjusted Means [2] 112.80
90% Confidence Interval ( 103.85 to 122.52 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)
Groups [1] Fesoterodine 4 mg 10% ER-BIC Fasted vs. Fesoterodine 4 mg ER Tablet Fasted
Ratio of Adjusted Means [2] 103.71
90% Confidence Interval ( 95.48 to 112.65 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)
Groups [1] Fesoterodine 4 mg 15% ER-BIC Fasted vs. Fesoterodine 4 mg ER Tablet Fasted
Ratio of Adjusted Means [2] 66.87
90% Confidence Interval ( 61.56 to 72.63 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)
Groups [1] Fesoterodine 4 mg 20% ER-BIC Fasted vs. Fesoterodine 4 mg ER Tablet Fasted
Ratio of Adjusted Means [2] 28.34
90% Confidence Interval ( 26.09 to 30.78 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)
Groups [1] Fesoterodine 4 mg 10% ER-BIC Fasted vs. Fesoterodine 4 mg 10% ER-BIC Fed
Ratio of Adjusted Means [2] 114.70
90% Confidence Interval ( 106.99 to 122.97 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.
[2] Other relevant estimation information:
  No text entered.



3.  Primary:   Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)   [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose ]

Measure Type Primary
Measure Title Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)
Measure Description No text entered.
Time Frame 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Reporting Groups
  Description
Fesoterodine 4 mg IR-BIC Fasted Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 10% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 15% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 20% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg ER Tablet Fasted Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 10% ER-BIC Fed Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.

Measured Values
    Fesoterodine 4 mg IR-BIC Fasted     Fesoterodine 4 mg 10% ER-BIC Fasted     Fesoterodine 4 mg 15% ER-BIC Fasted     Fesoterodine 4 mg 20% ER-BIC Fasted     Fesoterodine 4 mg ER Tablet Fasted     Fesoterodine 4 mg 10% ER-BIC Fed  
Number of Participants Analyzed  
[units: participants]
 		  20     20     20     20     20     20  
Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)  
[units: ng/mL]
Geometric Mean ± Standard Deviation 		  5.830  ± 2.729     3.030  ± 1.068     1.092  ± 0.496     0.323  ± 0.183     2.247  ± 1.000     5.183  ± 1.919  


Statistical Analysis 1 for Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)
Groups [1] Fesoterodine 4 mg IR-BIC Fasted vs. Fesoterodine 4 mg ER Tablet Fasted
Ratio of Adjusted Means [2] 259.40
90% Confidence Interval ( 231.48 to 290.70 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)
Groups [1] Fesoterodine 4 mg 10% ER-BIC Fasted vs. Fesoterodine 4 mg ER Tablet Fasted
Ratio of Adjusted Means [2] 134.83
90% Confidence Interval ( 120.31 to 151.09 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)
Groups [1] Fesoterodine 4 mg 15% ER-BIC Fasted vs. Fesoterodine 4 mg ER Tablet Fasted
Ratio of Adjusted Means [2] 48.58
90% Confidence Interval ( 43.35 to 54.44 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)
Groups [1] Fesoterodine 4 mg 20% ER-BIC Fasted vs. Fesoterodine 4 mg ER Tablet Fasted
Ratio of Adjusted Means [2] 14.38
90% Confidence Interval ( 12.83 to 16.11 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)
Groups [1] Fesoterodine 4 mg 10% ER-BIC Fasted vs. Fesoterodine 4 mg 10% ER-BIC Fed
Ratio of Adjusted Means [2] 171.06
90% Confidence Interval ( 115.82 to 187.78 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.
[2] Other relevant estimation information:
  No text entered.



4.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)   [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose ]

Measure Type Secondary
Measure Title Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)
Measure Description No text entered.
Time Frame 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Reporting Groups
  Description
Fesoterodine 4 mg IR-BIC Fasted Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 10% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 15% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 20% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg ER Tablet Fasted Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 10% ER-BIC Fed Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.

Measured Values
    Fesoterodine 4 mg IR-BIC Fasted     Fesoterodine 4 mg 10% ER-BIC Fasted     Fesoterodine 4 mg 15% ER-BIC Fasted     Fesoterodine 4 mg 20% ER-BIC Fasted     Fesoterodine 4 mg ER Tablet Fasted     Fesoterodine 4 mg 10% ER-BIC Fed  
Number of Participants Analyzed  
[units: participants]
 		  20     20     20     20     20     20  
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)  
[units: hr]
Median ( Full Range ) 		  1.0  
  ( 0.5 to 5.0 )   		  6.0  
  ( 5.0 to 8.0 )   		  6.0  
  ( 5.0 to 10.0 )   		  8.0  
  ( 5.0 to 24.0 )   		  5.0  
  ( 2.0 to 6.0 )   		  4.0  
  ( 3.0 to 6.0 )  

No statistical analysis provided for Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)



5.  Secondary:   Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)   [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose ]

Measure Type Secondary
Measure Title Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)
Measure Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.

Reporting Groups
  Description
Fesoterodine 4 mg IR-BIC Fasted Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 10% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 15% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 20% ER-BIC Fasted Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg ER Tablet Fasted Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
Fesoterodine 4 mg 10% ER-BIC Fed Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.

Measured Values
    Fesoterodine 4 mg IR-BIC Fasted     Fesoterodine 4 mg 10% ER-BIC Fasted     Fesoterodine 4 mg 15% ER-BIC Fasted     Fesoterodine 4 mg 20% ER-BIC Fasted     Fesoterodine 4 mg ER Tablet Fasted     Fesoterodine 4 mg 10% ER-BIC Fed  
Number of Participants Analyzed  
[units: participants]
 		  20     20     16     4     20     20  
Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)  
[units: hr]
Mean ± Standard Deviation 		  5.56  ± 1.70     7.22  ± 1.68     10.89  ± 4.45     NA  ± NA [1]   7.54  ± 2.49     4.59  ± 0.76  
[1] Parameter was missing for more than 50 percent of the participants.

No statistical analysis provided for Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)




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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01286454     History of Changes
Other Study ID Numbers: A0221068
Study First Received: December 3, 2010
Results First Received: December 1, 2011
Last Updated: January 24, 2012
Health Authority: United States: Food and Drug Administration