NCT01270815

An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers

An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered At Lunch Following Various Caloric Intakes As Compared To The Immediate Release Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (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

The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet following a 400 to 500 calorie, 600 to 750 calorie, or 800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following various sized lunches as compared to a single dose of the pregabalin immediate release capsule.

Detailed description

Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pregabalin controlled release, 330 mg, 400 to 500 calories	A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie medium-fat lunch
DRUG	Pregabalin controlled release, 330 mg, 600 to 750 calories	A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie medium-fat lunch
DRUG	Pregabalin controlled release, 330 mg, 800 to 1000 calories	A single oral dose of 330 mg controlled release tablet administered following an 800 to 1000 calorie medium-fat lunch
DRUG	Pregabalin immediate release, 300 mg	A single oral dose of 300 mg immediate release capsule administered fasted

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2011-01-05
• Last updated: 2021-01-22

Locations

1 site across 1 country: United States