Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect

Phase 1

Completed

• Conditions: Therapeutic Equivalency; Food
• Interventions: Drug: Fesoterodine

• Registration Number: NCT00807118
• Lead Sponsor: Pfizer

Brief Summary

Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial formulation in both under fasted and fed condition, and bioequivalence between formulation E(1) used in Japanese pivotal study and commercial formulation in 8 mg. Secondary objective is to assess food effect on 8 mg tablet of commercial formulation. These objectives are set to get data for Japanese regulatory submission.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-10
• Study First Posted: 2008-12-11
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-23
• Last Update Posted: 2010-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 108

Inclusion Criteria

• Japanese healthy male subject

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 (Cohort I)	Fesoterodine	-
C (Cohort I)	Fesoterodine	-
B (Cohort I)	Fesoterodine	-
D (Cohort II)	Fesoterodine	-
B (Cohort II)	Fesoterodine	-
E (Cohort II)	Fesoterodine	-

Primary Outcome Measures

Name	Time	Method
AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablets of formulation F under fed condition	Day 1 and 2
AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation Fand 1 tab of 8 mg fesoterodine SR tablets of formulation F under fasted condition	Day 1 and 2
AUCt and Cmax of 5-HMT under after single oral administration of 1 tab of 8 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablet of formulation E(1)	Day 1 and 2

Secondary Outcome Measures

Name	Time	Method
Tmax, AUClast, AUCinf, kel, t1/2 and MRT of all treatment	Day 1 and 2
AUCt and Cmax after single oral administration of 8 mg fesoterodine SR tablets of formulation F under fed condition in cohort II	Day 1 and 2

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Shinjuku-ku, Tokyo, Japan