The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fesoterodine Alone

Reference treatment

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

Single 8 mg oral dose of fesoterodine

fesoterodine plus fluconazole

Test treatment

Group Type OTHER

fesoterodine plus fluconazole

Intervention Type DRUG

On Day 1, fluconazole (200 mg oral dose) will be given 1 hour before and approximately 11 hour following a single 8 mg oral dose of fesoterodine (fesoterodine SD). Fluconazole will also be administered 200 mg BID on the Day 2 (ie, at approximately 24 and 36 hours following the fesoterodine SD treatment given on Day 1)

Interventions

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Fesoterodine

Single 8 mg oral dose of fesoterodine

Intervention Type DRUG

fesoterodine plus fluconazole

On Day 1, fluconazole (200 mg oral dose) will be given 1 hour before and approximately 11 hour following a single 8 mg oral dose of fesoterodine (fesoterodine SD). Fluconazole will also be administered 200 mg BID on the Day 2 (ie, at approximately 24 and 36 hours following the fesoterodine SD treatment given on Day 1)

Intervention Type DRUG