drugset / Trial / 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

NCT01009541

Phase 1 Completed 20 enrolled Viatris Inc.
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2009-11
Primary completion
2009-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregabalin Small molecule 82.5 mg
Subject Pregabalin Small molecule 150 mg
Subject Pregabalin Small molecule 165 mg
Subject Pregabalin Small molecule 330 mg

Indications

No indication recorded.