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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Fesoterodine SR4 (fed); Drug: Fesoterodine ER (fasted); Drug: Fesoterodine SR4 (fasted); Drug: Fesoterodine ER (fed); Drug: Fesoterodine SR3 (sprinkle); Drug: Fesoterodine SR4 (sprinkle); Drug: Fesoterodine SR3 (fasted); Drug: Fesoterodine SR3 (fed)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02160158

A0221099

2014-001248-39 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Cohort 1

Experimental group

Treatment:

Drug: Fesoterodine ER (fasted)

Drug: Fesoterodine SR3 (sprinkle)

Drug: Fesoterodine ER (fed)

Drug: Fesoterodine ER (fed)

Drug: Fesoterodine ER (fasted)

Drug: Fesoterodine SR3 (fed)

Drug: Fesoterodine SR3 (fasted)

Cohort 2

Experimental group

Treatment:

Drug: Fesoterodine SR4 (fed)

Drug: Fesoterodine ER (fasted)

Drug: Fesoterodine ER (fed)

Drug: Fesoterodine ER (fed)

Drug: Fesoterodine ER (fasted)

Drug: Fesoterodine SR4 (fasted)

Drug: Fesoterodine SR4 (sprinkle)