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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

December 3, 2010
January 24, 2012
December 2010
March 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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 - ∞).
  • 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 ] [ Designated as safety issue: No ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.
  • 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 ] [ Designated as safety issue: No ]
  • Cmax of 5-HMT [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • AUCinf of 5-HMT [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • AUClast of 5-HMT [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01286454 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Half-life of 5-HMT, as data permits. [ Time Frame: Up to 72 hours ] [ Designated as safety issue: No ]
  • Tmax of 5-HMT, as data permits. [ Time Frame: Up to 72 hours ] [ Designated as safety issue: No ]
  • Number of patients with adverse events. [ Time Frame: Up to 72 hours ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
An Open-Label, Single-Dose, Randomized, Cross-Over Study To Estimate The Bioavailability And Food Effect Of 4 Mg Fesoterodine Extended Release Beads-In-Capsule Formulations Compared To Commercial Tablet Formulation In Healthy Volunteers

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

To estimate the bioavailability of three different 4 mg fesoterodine ER beads-incapsule formulations compared to 4 mg fesoterodine marketed ER tablets under fasting and fed conditions.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency
  • Drug: fesoterodine
    single dose of beads in capsule
  • Drug: fesoterodine
    single dose of tablet
  • Experimental: A
    4 mg fesoterodine IR beads in capsule under fasting condition
    Intervention: Drug: fesoterodine
  • Experimental: B
    4 mg fesoterodine 10% coated ER beads in capsule under fasting condition
    Intervention: Drug: fesoterodine
  • Experimental: C
    4 mg fesoterodine 15% coated ER beads in capsule under fasting condition.
    Intervention: Drug: fesoterodine
  • Experimental: D
    4 mg fesoterodine 20% coated ER beads in capsule under fasting condition.
    Intervention: Drug: fesoterodine
  • Experimental: E
    4 mg fesoterodine ER tablets under fasting condition.
    Intervention: Drug: fesoterodine
  • Experimental: F
    4 mg fesoterodine TBD % coated ER beads in capsule under fed condition.
    Intervention: Drug: fesoterodine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years

Exclusion Criteria:

  • Evidence or history of clinically significant disease
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01286454
A0221068
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP