NCT01291524

Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers

An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Evaluate The Effects Of Caloric Content And Time Of Dosing On The Pharmacokinetics Of Pregabalin Controlled Release Formulation As Compared To The Immediate Release Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 (CR) tablet administered a) fasted at bedtime, b) immediately following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750 calorie evening meal as compared to a single dose of the pregabalin immediate release (IR)capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet administered with various caloric sized dinners and at bedtime 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 calorie	A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie evening meal
DRUG	Pregabalin controlled release, 330 mg, 600- 750 calorie	A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie evening meal
DRUG	Pregabalin controlled release, 330 mg, bedtime	A single oral dose of 330 mg controlled release tablet administered at bedtime
DRUG	Pregabalin immediate release, 300 mg	A single oral dose of 300 mg immediate release capsule administered in the evening

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2011-02-08
• Last updated: 2021-01-22

Locations

1 site across 1 country: United States