The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

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

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911235
• Other study ID #: A0221080
• Status: Completed
• Phase: Phase 1
• First received: May 28, 2009
• Last updated: May 31, 2011
• Start date: May 2009
• Est. completion date: July 2009

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Fesoterodine
Single 8 mg oral dose of fesoterodine
• 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)

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCinf and Cmax of 5-HMT		3 days per period	No
Secondary	AUClast, Tmax and half-life of 5-HMT as data permit.		3 days per period	No
Secondary	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	No

External Links

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