drugset / Trial / NCT01566760

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

NCT01566760

Phase 1 Completed 24 enrolled Pfizer
RandomizedCrossoverOpen-labelBasic science

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.

Timeline

Start
2012-05
Primary completion
2012-07
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fesoterodine Other / unclassified 4 mg

Indications