NCT01321671

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

The Pharmacokinetics Of Pregabalin Controlled Release Formulation In Fed State Compared To The Controlled Release And Immediate Release Formulations In The Fasted State

• 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 evaluate the pharmacokinetics of a single dose of a pregabalin controlled release (CR) tablet administered fasted in the evening relative to a single dose of the CR tablet administered immediately following a 600 to 750 calorie evening meal. The single dose pharmacokinetics of the pregabalin CR administered fed or fasted will also be compared to the single dose pharmacokinetics of the pregabalin immediate release (IR) capsule. In addition, the safety and tolerability of these 3 treatments will be evaluated.

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, 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, fasted	A single oral dose of 330 mg controlled release tablet administered fasted in the evening
DRUG	Pregabalin immediate release, 300 mg	A single oral dose of 300 mg immediate release capsule administered in the evening

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-03-23
• Last updated: 2021-01-22

Locations

1 site across 1 country: United States