Skip to main content
OpenTrials
Completed

NCT Number: NCT00914667

The Effect Of Fesoterodine On Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects

This is an open-label, randomized, two-way crossover study to evaluate the steady-state effect of fesoterodine (8 mg QD) on the pharmacodynamics and pharmacokinetics of a single supratherapeutic dose of warfarin (25 mg) in healthy subjects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations

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 between the ages of 18 and 55 years

Exclusion criteria

  • Not healthy subjects--subjects with acute or chronic medical or psychiatric conditions or laboratory abnormality

Treatment and study plan

Warfarin

Drug

Single Dose Warfarin 25 mg on Day 1

Warfarin plus Fesoterodine

Drug

Fesoterodine 8 mg ER tablets QD for 9 Days and Single Dose Warfarin 25 mg on Day 3

Primary outcomes

  1. Cmax and AUCinf for both S- and R-warfarin

    Time frame: 8 days per period

  2. AUC_INR and INRmax

    Time frame: 8 days per period

Secondary outcomes

  1. AUClast, Tmax and t½ for both S- and R-warfarin

    Time frame: 8 days per period

  2. AUC_PT and PTmax

    Time frame: 8 days per period

  3. Safety will be assessed by subjective symptoms/objective findings including physical examinations, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring.

    Time frame: 8 days per period

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open-Label, Randomized, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Fesoterodine On The Pharmacokinetics And Pharmacodynamics Of A Single Supratherapeutic Dose Of Warfarin In Healthy Subjects.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 5, 2009
Registry last updated
Jun 1, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.