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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01286454
First Posted: January 31, 2011
Last Update Posted: January 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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
Intervention Model: Crossover Assignment
Masking: None (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:


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 ]
    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 ]
    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 ]

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 ]
  • 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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01286454     History of Changes
Other Study ID Numbers: A0221068
First Submitted: December 3, 2010
First Posted: January 31, 2011
Results First Submitted: December 1, 2011
Results First Posted: January 9, 2012
Last Update Posted: January 26, 2012
Last Verified: January 2012

Keywords provided by Pfizer:
BIOAVAILABILITY
FOOD EFFECT

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents