The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence

Treatments: Drug: Fesoterodine; Drug: fesoterodine plus fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00911235

A0221080

Details and patient eligibility

About

This study is designed to estimate the effect of fluconazole (200 mg BID for 2 days), a moderate CYP3A4 inhibitor on the pharmacokinetics of a single 8 mg oral dose of fesoterodine in healthy adult subjects.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects between the ages of 18 and 55 years

Exclusion criteria

• Not healthy subjects. subjects with acute or chronic medical or psychiatric condition or laboratory abnormality

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Fesoterodine Alone

Experimental group

Description:

Reference treatment

Treatment:

Drug: Fesoterodine

fesoterodine plus fluconazole

Other group

Description:

Test treatment

Treatment:

Drug: fesoterodine plus fluconazole