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

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ClinicalTrials.gov Identifier: NCT00914667
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : June 1, 2011
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Urinary Bladder, Overactive Drug: warfarin Drug: Warfarin plus Fesoterodine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : July 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00914667     History of Changes
Other Study ID Numbers: A0221079
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011

Keywords provided by Pfizer:
Overactive Bladder Urgency Frequency

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Warfarin
Fesoterodine
Anticoagulants
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents