A Open-label, Randomized, Crossover Study to Assess PK of Pregabalin

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this trial to compare the pharmacokinetic characteristics of YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled release formulation which is made by Yuhan Corporation. Primary endpoints are Cmax,ss and AUCtau and secondary endpoints are AUClast,ss, AUCinf,ss, Tmax,ss and t1/2.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• 19~50 years old, healthy male volunteers

• >55Kg(Body weight) and 18.5Exclusion Criteria:

• AST or ALT > 3 * Upper normal range (Lab)

• Total bilirubin > 2.0 mg/dl

• Systolic BP >140 OR <90, Diastolic BP >100 OR <60