The Effect Of Fesoterodine On Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects
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.
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2009
CompletedFirst Posted
Study publicly available on registry
June 5, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedJune 1, 2011
May 1, 2011
1 month
June 3, 2009
May 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cmax and AUCinf for both S- and R-warfarin
8 days per period
AUC_INR and INRmax
8 days per period
Secondary Outcomes (3)
AUClast, Tmax and t½ for both S- and R-warfarin
8 days per period
AUC_PT and PTmax
8 days per period
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.
8 days per period
Study Arms (2)
Warfarin Alone
EXPERIMENTALReference treatment
Warfarin Concomitantly With Fesoterodine
EXPERIMENTALTest treatment
Interventions
Fesoterodine 8 mg ER tablets QD for 9 Days and Single Dose Warfarin 25 mg on Day 3
Eligibility Criteria
You may qualify if:
- Healthy male and/or female subjects between the ages of 18 and 55 years
You may not qualify if:
- Not healthy subjects--subjects with acute or chronic medical or psychiatric conditions or laboratory abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 3, 2009
First Posted
June 5, 2009
Study Start
July 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
June 1, 2011
Record last verified: 2011-05