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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00914667

Enrollment

Registered

2009-06-05

Start date

2009-07-31

Completion date

2009-08-31

Last updated

2011-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder, Overactive

Keywords

Overactive Bladder Urgency Frequency

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.

Interventions

DRUGwarfarin

Single Dose Warfarin 25 mg on Day 1

DRUGWarfarin plus Fesoterodine

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUC_INR and INRmax	8 days per period
Cmax and AUCinf for both S- and R-warfarin	8 days per period

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026