NCT00807118

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

A Phase 1, Open-Label, Randomized, Single-Dose, 2-Cohort, 3-Way Crossover Study To Determine Bioequivalence Of 4 Mg And 8 Mg Fesoterodine SR Tablet Of Commercial Formulation And 8 Mg Fesoterodine SR Tablet Between Formulation E(1) And Formulation F And Investigate Food Effect On Commercial Formulation In Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Pfizer · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Therapeutic Equivalency
• Food

Interventions

Type	Name	Description
DRUG	Fesoterodine	Single dose of 2 x 4 mg tab in formulation F under fed condition
DRUG	Fesoterodine	Single dose of 1 x 8 mg tab in formulation F under fed condition
DRUG	Fesoterodine	Single dose of 1 x 8 mg tab in formulation E(1) under fed condition
DRUG	Fesoterodine	Single dose of 1 x 8 mg tab in formulation F under fed condition
DRUG	Fesoterodine	Single dose of 2 x 4 mg tab in formulation F under fasted condition
DRUG	Fesoterodine	Single dose of 1 x 8 mg tab in formulation F under fasted condition

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-12-11
• Last updated: 2010-03-24

Locations

1 site across 1 country: Japan