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Completed

NCT Number: NCT00902681

A Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects

This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.

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Key information

Conditions

Treatment of Overactive Bladder

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and/or female subjects
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion criteria

  • Subjects with evidence or history of clinically significant urologic diseases
  • A positive urine drug screen
  • Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method

Treatment and study plan

Fesoterodine

Drug

A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg

Other names: Toviaz 8 mg

Primary outcomes

  1. AUCinf, AUClast, and Cmax of 5-HMT

    Time frame: 6 weeks

Secondary outcomes

  1. Tmax and half-life of 5-HMT as data permit.

    Time frame: 6 weeks

  2. Safety laboratory tests and adverse events

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open-Label, Randomized, Single-Dose, Two-Way Crossover Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™), Manufactured At Zwickau Versus Vega Baja, In Healthy Subjects.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 15, 2009
Registry last updated
Sep 28, 2018

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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