Skip to main content
OpenTrials
Completed

NCT Number: NCT00911235

The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fesoterodine

Drug

Single 8 mg oral dose of fesoterodine

fesoterodine plus fluconazole

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)

Primary outcomes

  1. AUCinf and Cmax of 5-HMT

    Time frame: 3 days per period

Secondary outcomes

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

    Time frame: 3 days per period

  2. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open-Label, Randomized, Two-Way Crossover Study To Evaluate The Effect Of Fluconazole, A Moderate CYP3A4 Inhibitor, On The Single-Dose Pharmacokinetics Of Fesoterodine In Healthy Subjects.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 1, 2009
Registry last updated
Jun 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.