NCT01443169 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

April 30, 2012

Study Completion Date

April 30, 2012

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.

Trial Locations (1)

B-1070

Pfizer Investigational Site, Brussels

All Listed Sponsors

lead

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

INDUSTRY