NCT01257516

An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers

An Open-Label, Multiple-Dose, Randomized, 2-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of 660 Mg (2 X 330 Mg Tablets) Pregabalin Controlled Release Formulation Administered Following An Evening Meal Relative To The 300 Mg Of The Immediate Release Formulation Administered Twice Daily

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (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 multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule.

Detailed description

Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pregabalin immediate release, 300 mg	300 mg immediate release capsule administered twice daily for four days
DRUG	Pregabalin controlled release, 330 mg	Two tablets of 330 mg (total dose of 660 mg) given concurrently once daily for four days

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2010-12-09
• Last updated: 2021-01-22

Locations

1 site across 1 country: Belgium