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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect Of Fesoterodine On Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects

NCT00914667

Urinary Bladder, Overactive

COMPLETED PHASE1

An Open-Label Food Effect Study of Telotristat Etiprate

NCT02157584

Healthy

COMPLETED PHASE1

Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers

NCT04479800

Healthy Volunteer

COMPLETED PHASE1

Furosemide Pharmacodynamics and Pharmacokinetics After Subcutaneous or Oral Administration

NCT02350725

Heart Failure

COMPLETED PHASE1/PHASE2

Pharmacokinetics and Food Effect of Single Oral Dose of E7050 in Healthy Volunteers

NCT02533102

Healthy Subjects

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Bladder, Overactive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment A, Cohort 1

Group Type EXPERIMENTAL

fesoterodine fumarate

Intervention Type DRUG

One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose

Treatment B, Cohort 2

Group Type EXPERIMENTAL

fesoterodine fumarate

Intervention Type DRUG

One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose

Treatment C, Cohort 1

Group Type EXPERIMENTAL

fesoterodine fumarate

Intervention Type DRUG

One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose

Treatment D, Cohort 2

Group Type EXPERIMENTAL

fesoterodine fumarate

Intervention Type DRUG

One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose

Treatment E, Cohort 1 and/or Cohort 2

Group Type ACTIVE_COMPARATOR

fesoterodine fumarate

Intervention Type DRUG

one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fesoterodine fumarate

One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose

Intervention Type DRUG

fesoterodine fumarate

One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose

Intervention Type DRUG

fesoterodine fumarate

One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose

Intervention Type DRUG

fesoterodine fumarate

One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose

Intervention Type DRUG

fesoterodine fumarate

one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.).

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes