drugset / Trial / NCT02327000

A Randomized, Open-label, Single Dose, Parallel Study to Evaluate the Pharmacokinetics Dose Proportionality of GLA5PR GLARS-NF1 Tablet in Healthy Male Volunteers

NCT02327000

Phase 1 Completed 40 enrolled GL Pharm Tech Corporation
RandomizedParallel-groupOpen-labelBasic science

Summary

The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".

Timeline

Start
2014-10
Primary completion
2014-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregabalin Small molecule 150 mg
Subject Pregabalin Small molecule 300 mg
Subject Pregabalin Small molecule 450 mg
Subject Pregabalin Small molecule 600 mg

Indications

No indication recorded.