The Effect Of Fesoterodine On Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00914667

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics/Dynamics Study
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:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Warfarin Fesoterodine Fesoterodine fumarate Warfarin sodium Warfarin potassium

U.S. FDA Resources

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
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Warfarin Alone: Experimental Reference treatment	Drug: warfarin Single Dose Warfarin 25 mg on Day 1
Warfarin Concomitantly With Fesoterodine: Experimental 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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0221079
Study First Received:	June 3, 2009
Last Updated:	July 9, 2009
ClinicalTrials.gov Identifier:	NCT00914667 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Overactive Bladder Urgency Frequency

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Anticoagulants
Cystocele

Urologic Diseases
Urinary Bladder Diseases
Warfarin
Healthy

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Bladder, Overactive
Anticoagulants
Urologic Diseases

Therapeutic Uses
Hematologic Agents
Urinary Bladder Diseases
Warfarin
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 03, 2009