A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of the drug. This study will take place over approximately 8 weeks and will consist of a screening visit to determine eligibility for the study, and 2- or 3-period treatment phase for each cohort.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Fesoterodine; Tolterodine Tartrate

Criteria

Inclusion Criteria:

• Healthy male and/or female subjects between 21 and 55 years of age(inclusive).

Exclusion Criteria:

• Evidence or history of clinically significant disease.

• Evidence or history of urologic disease (benign prostate hyperplasia, recurrent urinary tract infections, urinary retention, etc.).