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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
  Purpose

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


Condition Intervention Phase
Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency
 Drug: fesoterodine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
4 mg fesoterodine IR beads in capsule under fasting condition
 Drug: fesoterodine
single dose of beads in capsule
Experimental: B
4 mg fesoterodine 10% coated ER beads in capsule under fasting condition
 Drug: fesoterodine
single dose of beads in capsule
Experimental: C
4 mg fesoterodine 15% coated ER beads in capsule under fasting condition.
 Drug: fesoterodine
single dose of beads in capsule
Experimental: D
4 mg fesoterodine 20% coated ER beads in capsule under fasting condition.
 Drug: fesoterodine
single dose of beads in capsule
Experimental: E
4 mg fesoterodine ER tablets under fasting condition.
 Drug: fesoterodine
single dose of tablet
Experimental: F
4 mg fesoterodine TBD % coated ER beads in capsule under fed condition.
 Drug: fesoterodine
single dose of beads in capsule

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286454

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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

Keywords provided by Pfizer:
BIOAVAILABILITY
FOOD EFFECT

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013