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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014