Phase1, Single Dose, Crossover Study to Determine Bioequivalence

September 8, 2010 updated by: Pfizer

A Phase 1, Open-Label, Randomized, Single-Dose, 2-Way Crossover Study To Determine Bioequivalence Of 4 Mg Fesoterodine SR Tablet Between Formulation D And Formulation E(1) In Healthy Subjects.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

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

  • Singapore
      • Singapore, Singapore, 188770
        • 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

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male or female Chinese or Japanese subjects

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
Drug: Fesoterodine
Single dose of 4 mg tablet in formulation D under fasted conditions (Reference)
Drug: Fesoterodine
Single dose of 4 mg tablet in formulation E(1) under fasted conditions (Test)
Experimental: B
Drug: Fesoterodine
Single dose of 4 mg tablet in formulation D under fasted conditions (Reference)
Drug: Fesoterodine
Single dose of 4 mg tablet in formulation E(1) under fasted conditions (Test)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Day 1 and 2

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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

January 1, 2009

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

November 5, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 6, 2008

Study Record Updates

Last Update Posted (Estimate)

September 9, 2010

Last Update Submitted That Met QC Criteria

September 8, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0221063

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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