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

Pfizer14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urinary Bladder, Overactive

Interventions

warfarinDRUG

Single Dose Warfarin 25 mg on Day 1

Warfarin plus FesoterodineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Cmax and AUCinf for both S- and R-warfarin

Time frame: 8 days per period

AUC_INR and INRmax

Time frame: 8 days per period

Secondary Outcomes

AUClast, Tmax and t½ for both S- and R-warfarin

Time frame: 8 days per period

AUC_PT and PTmax

Time frame: 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.

Time frame: 8 days per period

Data from ClinicalTrials.gov

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