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

Phase 1

Completed

• Conditions: Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency
• Interventions: Drug: fesoterodine

• Registration Number: NCT01286454
• Lead Sponsor: Pfizer

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2011-01-28
• Study First Posted: 2011-01-31
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2011-12-01
• Results First Submitted QC: 2011-12-01
• Status Verified: 2012-01
• Results First Posted: 2012-01-09
• Last Update Submitted: 2012-01-24
• Last Update Posted: 2012-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	fesoterodine	4 mg fesoterodine IR beads in capsule under fasting condition
C	fesoterodine	4 mg fesoterodine 15% coated ER beads in capsule under fasting condition.
B	fesoterodine	4 mg fesoterodine 10% coated ER beads in capsule under fasting condition
D	fesoterodine	4 mg fesoterodine 20% coated ER beads in capsule under fasting condition.
E	fesoterodine	4 mg fesoterodine ER tablets under fasting condition.
F	fesoterodine	4 mg fesoterodine TBD % coated ER beads in capsule under fed condition.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])	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)	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)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose

Secondary Outcome Measures

Name	Time	Method
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
Plasma Decay Half Life (t1/2) 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	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States