Phase1, Single Dose, Crossover Study to Determine Bioequivalence

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Fesoterodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00786240

A0221063

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female Chinese or Japanese subjects

Exclusion criteria

• Evidence or history of clinically significant findings at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Fesoterodine

Drug: Fesoterodine

B

Experimental group

Treatment:

Drug: Fesoterodine

Drug: Fesoterodine