The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

Pfizer28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

FesoterodineDRUG

Single 8 mg oral dose of fesoterodine

fesoterodine plus fluconazoleDRUG

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)

Eligibility

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

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

AUCinf and Cmax of 5-HMT

Time frame: 3 days per period

Secondary Outcomes

AUClast, Tmax and half-life of 5-HMT as data permit.

Time frame: 3 days per period

Safety will be assessed by subjective symptoms/objective findings including physical examination findings, clinical safety laboratory assessments and adverse event monitoring.

Time frame: 3 days per period

Data from ClinicalTrials.gov

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