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OpenTrials
Completed

NCT Number: NCT00786240

Phase1, Single Dose, Crossover Study to Determine Bioequivalence

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

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Key information

Conditions

Healthy

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female Chinese or Japanese subjects

Exclusion criteria

  • Evidence or history of clinically significant findings at screening

Treatment and study plan

Fesoterodine

Drug

Single dose of 4 mg tablet in formulation D under fasted conditions (Reference)

Primary outcomes

  1. 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

  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

Secondary outcomes

  1. 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

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 6, 2008
Registry last updated
Sep 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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