A 5-treatment, Study in Healthy Volunteers to Assess The Safety, Tolerability, and Pharmacokinetics of Four Controlled Release (CR) Pregabalin Tablet Formulations and the Immediate Release (IR) Formulation Administered Fasted

Summary

This study is an open-label, single dose, randomized, 5-period, 5-treatment, 4-sequence cross-over with a fixed 5th treatment arm. Subjects will receive in a randomized sequence a 330 mg CR tablet with fast in vitro dissolution rate, a 330 mg CR tablet with slow in vitro dissolution rate, a heavier 330 mg CR tablet with fast in vitro dissolution rate or a 330 mg market image reference CR tablet. Subjects will receive a 300mg IR formulation in the 5th period to to estimate and compare the % of dose absorbed versus time profile for the three CR prototype tablets and the CR reference tablet.

Conditions

• Healthy

Interventions

DRUG

Sequence 1 - Treatment A: Controlled Release Pregabalin

330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 1 - Treatment B: Controlled Release Pregabalin

330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 1 - Treatment C:Controlled Release Pregabalin

330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 1 - Treatment D: Controlled Release Pregabalin

330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 1 - Treatment E: Immediate Release Pregabalin

300 mg IR capsule administered in the evening in the fasted state.

DRUG

Sequence 2 - Treatment B: Controlled Release Pregabalin

330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 2 - Treatment D: Controlled Release Pregabalin

330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 2 - Treatment A: Controlled Release Pregabalin

330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 2 - Treatment C: Controlled Release Pregabalin

330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 2 - Treatment E: Immediate Release Pregabalin

300 mg IR capsule administered in the evening in the fasted state.

DRUG

Sequence 3 - Treatment C: Controlled Release Pregabalin

330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 3 - Treatment A: Controlled Release Pregabalin

330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 3 - Treatment D: Controlled Release Pregabalin

330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 3 - Treatment B: Controlled Release Pregabalin

330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 3 - Treatment E: Immediate Release Pregabalin

300 mg IR capsule administered in the evening in the fasted state.

DRUG

Sequence 4 - Treatment D: Controlled Release Pregabalin

330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 4 - Treatment C: Controlled Release Pregabalin

330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 4 - Treatment B: Controlled Release Pregabalin

330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 4 - Treatment A: Controlled Release Pregabalin

330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.

DRUG

Sequence 4 - Treatment E: Immediate Release Pregabalin

300 mg IR capsule administered in the evening in the fasted state.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

  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

2012-03-31

Primary Completion

2012-04-30

Completion

2012-04-30

Countries

• Belgium

Study Locations