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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00914667
First received: June 3, 2009
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Urinary Bladder, Overactive
Drug: warfarin
Drug: Warfarin plus Fesoterodine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Cmax and AUCinf for both S- and R-warfarin [ Time Frame: 8 days per period ] [ Designated as safety issue: No ]
  • AUC_INR and INRmax [ Time Frame: 8 days per period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUClast, Tmax and t½ for both S- and R-warfarin [ Time Frame: 8 days per period ] [ Designated as safety issue: No ]
  • AUC_PT and PTmax [ Time Frame: 8 days per period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Warfarin Alone
Reference treatment
Drug: warfarin
Single Dose Warfarin 25 mg on Day 1
Experimental: Warfarin Concomitantly With Fesoterodine
Test treatment
Drug: Warfarin plus Fesoterodine
Fesoterodine 8 mg ER tablets QD for 9 Days and Single Dose Warfarin 25 mg on Day 3

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914667

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00914667     History of Changes
Other Study ID Numbers: A0221079
Study First Received: June 3, 2009
Last Updated: May 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Overactive Bladder Urgency Frequency

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014