Randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A, YHD1119 B, YHD1119 C and Lyrica capsule.

YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation.

Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity, T max,ss, t 1/2

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

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• 20~45 years old, healthy adult male subject

• >55 Kg(Body weight) and < ideal body weight ± 20%

Exclusion Criteria:

• AST or ALT > 1.25 * Upper normal range (Lab)

• Total bilirubin > 1.5 * Upper normal range

• Systolic BP >140 OR <100, Diastolic BP >90 OR <65