Phase1, Single Dose, Crossover Study to Determine Bioequivalence

Phase 1CompletedNCT00786240

Pfizer37 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

FesoterodineDRUG

Single dose of 4 mg tablet in formulation D under fasted conditions (Reference)

FesoterodineDRUG

Single dose of 4 mg tablet in formulation E(1) under fasted conditions (Test)

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male or female Chinese or Japanese subjects Exclusion Criteria: * Evidence or history of clinically significant findings at screening

Locations (1)

Pfizer Investigational Site

Singapore, Singapore, Singapore

Outcomes

Primary Outcomes

AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions

Time frame: 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

Time frame: Day 1 and 2

Secondary Outcomes

Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions

Time frame: 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

Time frame: Day 1 and 2

Data from ClinicalTrials.gov

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