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

A Phase 1, Randomized, Open Label, Single Dose, 5-treatment, 5- Period Crossover Study in Healthy Volunteers to Assess The Safety, Tolerability, and Pharmacokinetics of Four Controlled Release Pregabalin Tablet Formulations Administered Following an Evening Meal and the Immediate Release Formulation Administered Fasted

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-09-29
• Last updated: 2021-01-22

Locations

1 site across 1 country: Belgium