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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Urinary Bladder, Overactive

Treatments: Drug: Warfarin plus Fesoterodine; Drug: warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00914667

A0221079

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Warfarin Alone

Experimental group

Description:

Reference treatment

Treatment:

Drug: warfarin

Warfarin Concomitantly With Fesoterodine

Experimental group

Description:

Test treatment

Treatment:

Drug: Warfarin plus Fesoterodine