The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

Phase 1

Completed

• Conditions: Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence
• Interventions: Drug: fesoterodine plus fluconazole; Drug: Fesoterodine

• Registration Number: NCT00911235
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-06-01
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
fesoterodine plus fluconazole	fesoterodine plus fluconazole	Test treatment
Fesoterodine Alone	Fesoterodine	Reference treatment

Primary Outcome Measures

Name	Time	Method
AUCinf and Cmax of 5-HMT	3 days per period

Secondary Outcome Measures

Name	Time	Method
AUClast, Tmax and half-life of 5-HMT as data permit.	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.	3 days per period

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States