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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-08-19

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01566760 on ClinicalTrials.gov