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

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).

Conditions

• Healthy

Interventions

DRUG

Fesoterodine ER (fasted)

Commercial Fesoterodine ER 4 mg (single dose)

DRUG

Fesoterodine SR3 (fasted)

Fesoterodine SR3 4 mg (single dose)

DRUG

Fesoterodine SR3 (fed)

Fesoterodine SR3 4 mg (single dose) with high-fat meal

DRUG

Fesoterodine ER (fed)

Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal

DRUG

Fesoterodine SR3 (sprinkle)

Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce

DRUG

Fesoterodine ER (fasted)

Commercial Fesoterodine ER 4 mg (single dose)

DRUG

Fesoterodine SR4 (fasted)

Fesoterodine SR4 4 mg (single dose)

DRUG

Fesoterodine SR4 (fed)

Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal

DRUG

Fesoterodine ER (fed)

Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal

DRUG

Fesoterodine SR4 (sprinkle)

Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-07-31

Primary Completion

2014-12-31

Completion

2014-12-31

Countries

• Belgium

Study Locations