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

NCT ID: NCT00807118

Last Updated: 2010-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Therapeutic Equivalency Food

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A (Cohort I)

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

Single dose of 2 x 4 mg tab in formulation F under fed condition

B (Cohort I)

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

Single dose of 1 x 8 mg tab in formulation F under fed condition

C (Cohort I)

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

Single dose of 1 x 8 mg tab in formulation E(1) under fed condition

B (Cohort II)

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

Single dose of 1 x 8 mg tab in formulation F under fed condition

D (Cohort II)

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

Single dose of 2 x 4 mg tab in formulation F under fasted condition

E (Cohort II)

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

Single dose of 1 x 8 mg tab in formulation F under fasted condition

Interventions

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Fesoterodine

Single dose of 2 x 4 mg tab in formulation F under fed condition

Intervention Type DRUG

Fesoterodine

Single dose of 1 x 8 mg tab in formulation F under fed condition

Intervention Type DRUG

Fesoterodine

Single dose of 1 x 8 mg tab in formulation E(1) under fed condition

Intervention Type DRUG

Fesoterodine

Single dose of 1 x 8 mg tab in formulation F under fed condition

Intervention Type DRUG

Fesoterodine

Single dose of 2 x 4 mg tab in formulation F under fasted condition

Intervention Type DRUG

Fesoterodine

Single dose of 1 x 8 mg tab in formulation F under fasted condition

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Japanese healthy male subject

Exclusion Criteria

* Evidence or history of clinically significant findings at screening
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221052&StudyName=Phase%201%2C%20single%20dose%2C%20crossover%20study%20to%20determine%20bioequivalence%20and%20to%20investigate%20food%20effect

To obtain contact information for a study center near you, click here.

Other Identifiers

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A0221052

Identifier Type: -

Identifier Source: org_study_id

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