NCT01257529

An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal 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 Evaluate The Effects Of A Low, Medium And High Fat Evening Meal On The Pharmacokinetics Of Pregabalin Controlled Release Formulation 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 either a low, medium, or high-fat evening meal as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following a low, medium, or high fat evening meal 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, low-fat	A single oral dose of 330 mg controlled release tablet administered following a low-fat evening meal
DRUG	Pregabalin controlled release, 330 mg, medium-fat	A single oral dose of 330 mg controlled release tablet administered following a medium-fat evening meal
DRUG	Pregabalin controlled release, 330 mg, high-fat	A single oral dose of 330 mg controlled release tablet administered following a high-fat evening meal
DRUG	Pregabalin immediate release, 300 mg	A single oral dose of 300 mg immediate release capsule administered following a medium-fat evening meal

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-12-09
• Last updated: 2021-01-22

Locations

1 site across 1 country: United States