Study to Estimate the Relative Bioavailability Compared to Commercial Extended-release Tablet Formulation and the Effects of Food Or Sprinkling on Applesauce for Fesoterodine Sustained-release Beads-in-capsule Formulations in Healthy Adult Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Fesoterodine ER (fasted); Drug: Fesoterodine SR3 (fasted); Drug: Fesoterodine SR4 (fasted); Drug: Fesoterodine SR3 (fed); Drug: Fesoterodine SR4 (fed); Drug: Fesoterodine ER (fed); Drug: Fesoterodine SR4 (sprinkle); Drug: Fesoterodine SR3 (sprinkle)

• Registration Number: NCT02160158
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to evaluate the relative bioavailability of 2 new bead-in-capsule formulations compared to the commercial extended-release formulation (both fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-10
• Study Start: 2014-07
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-14
• Last Update Posted: 2015-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy male and/or female subjects between the ages of 18 and 55 years; Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Exclusion Criteria

• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
• History of uncontrolled narrow angle glaucoma, myasthenia gravis, gastric retention, severe ulcerative colitis and toxic megacolon
• Evidence or history of clinically significant urologic disease [urinary retention, obstructive disturbance of bladder emptying, micturition disturbance, nocturia or pollacisuria (eg, benign prostate hyperplasia, urethral stricture, recurrent urinary tract infections); Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes/day

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1	Fesoterodine SR3 (fed)	-
Cohort 1	Fesoterodine ER (fed)	-
Cohort 2	Fesoterodine SR4 (sprinkle)	-
Cohort 1	Fesoterodine SR3 (sprinkle)	-
Cohort 2	Fesoterodine ER (fed)	-
Cohort 2	Fesoterodine ER (fasted)	-
Cohort 1	Fesoterodine SR3 (fasted)	-
Cohort 1	Fesoterodine ER (fasted)	-
Cohort 2	Fesoterodine SR4 (fasted)	-
Cohort 2	Fesoterodine SR4 (fed)	-

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	48 hours
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	48 hours	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	48 hours	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time to Reach Maximum Observed Plasma Concentration (Tmax)	48 hours
Plasma Decay Half-Life (t1/2)	48 hours	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium