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

Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286454
• Other study ID #: A0221068
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2010
• Last updated: January 24, 2012
• Start date: December 2010
• Est. completion date: March 2011

Study information

• Verified date: January 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency
• Urinary Bladder, Overactive

Intervention

Drug:
• fesoterodine
single dose of beads in capsule
• fesoterodine
single dose of beads in capsule
• fesoterodine
single dose of beads in capsule
• fesoterodine
single dose of beads in capsule
• fesoterodine
single dose of tablet
• fesoterodine
single dose of beads in capsule

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])	AUC (0 - 8) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose	No
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose	No
Primary	Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose	No
Secondary	Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose	No

External Links

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