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

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

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

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