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

Open-Label, Single-Dose, Randomized, Crossover Study To Estimate The Effects Of Food On The Pharmacokinetics Of Two Fesoterodine Sustained-Release Beads-In-Capsule Formulations And To Estimate The Relative Bioavailability Of One Or Both Formulations Compared To Commercial Tablet Formulation In Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DRUG	fesoterodine fumarate	One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose
DRUG	fesoterodine fumarate	One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose
DRUG	fesoterodine fumarate	One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose
DRUG	fesoterodine fumarate	One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose
DRUG	fesoterodine fumarate	one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-03-29
• Last updated: 2016-08-19

Locations

1 site across 1 country: Singapore