NCT01009541

An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule

An Open-Label, Multiple-Dose, Randomized, Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Three Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal As Compared To The Immediate Release Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (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 three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pregabalin controlled release, 82.5 mg	82.5 mg controlled release tablet administered once daily for three days.
DRUG	Pregabalin controlled release, 165 mg	165 mg controlled release tablet administered once daily for three days.
DRUG	Pregabalin controlled release, 330 mg	330 mg controlled release tablet administered once daily for three days.
DRUG	Pregabalin immediate release, 150 mg	150 mg immediate release capsules administered every 12 hours for three days

Timeline

• Start date: 2009-11-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-11-06
• Last updated: 2021-01-22

Locations

1 site across 1 country: Belgium