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

March 23, 2010 updated by: Pfizer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Japanese healthy male subject

Exclusion Criteria:

  • Evidence or history of clinically significant findings at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A (Cohort I)
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 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
Experimental: B (Cohort I)
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 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
Experimental: C (Cohort I)
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 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
Experimental: B (Cohort II)
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 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
Experimental: D (Cohort II)
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 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
Experimental: E (Cohort II)
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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablets of formulation F under fed condition
Time Frame: Day 1 and 2
Day 1 and 2
AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation Fand 1 tab of 8 mg fesoterodine SR tablets of formulation F under fasted condition
Time Frame: Day 1 and 2
Day 1 and 2
AUCt and Cmax of 5-HMT under after single oral administration of 1 tab of 8 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablet of formulation E(1)
Time Frame: Day 1 and 2
Day 1 and 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Tmax, AUClast, AUCinf, kel, t1/2 and MRT of all treatment
Time Frame: Day 1 and 2
Day 1 and 2
AUCt and Cmax after single oral administration of 8 mg fesoterodine SR tablets of formulation F under fed condition in cohort II
Time Frame: Day 1 and 2
Day 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria

December 10, 2008

First Posted (Estimate)

December 11, 2008

Study Record Updates

Last Update Posted (Estimate)

March 24, 2010

Last Update Submitted That Met QC Criteria

March 23, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0221052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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