Phase1, Single Dose, Crossover Study to Determine Bioequivalence

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Fesoterodine

• Registration Number: NCT00786240
• Lead Sponsor: Pfizer

Brief Summary

The objective of this study is to demonstrate bioequivalence of 4 mg tablet of formulation D and formulation E(1).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-06
• Study Start: 2009-01
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-08
• Last Update Posted: 2010-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Healthy male or female Chinese or Japanese subjects

Exclusion Criteria

• Evidence or history of clinically significant findings at screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Fesoterodine	-
B	Fesoterodine	-

Primary Outcome Measures

Name	Time	Method
AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions	Day 1 and 2
AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation E(1) under fasted conditions	Day 1 and 2

Secondary Outcome Measures

Name	Time	Method
Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions	Day 1 and 2
Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation E(1) under fasted conditions	Day 1 and 2

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore