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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Therapeutic Equivalency

Food

Treatments

Drug: Fesoterodine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00807118

A0221052

Details and patient eligibility

About

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.

Enrollment

108 estimated patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Japanese healthy male subject

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)

108 participants in 6 patient groups

A (Cohort I)

Experimental group

Treatment:

Drug: Fesoterodine

B (Cohort I)

Experimental group

Treatment:

Drug: Fesoterodine

C (Cohort I)

Experimental group

Treatment:

Drug: Fesoterodine

B (Cohort II)

Experimental group

Treatment:

Drug: Fesoterodine

D (Cohort II)

Experimental group

Treatment:

Drug: Fesoterodine

E (Cohort II)

Experimental group

Treatment:

Drug: Fesoterodine

Trial contacts and locations

1

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