drugset / Trial / NCT01220219

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

NCT01220219

Phase 1 Completed 24 enrolled Viatris Inc.
RandomizedCrossoverOpen-labelOther

Summary

The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two 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 two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.

Timeline

Start
2010-11
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregabalin Small molecule 75 mg
Subject Pregabalin Small molecule 82.5 mg
Subject Pregabalin Small molecule 165 mg

Indications

No indication recorded.