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

A Open-label, Radomized, Crossover Clinical Trial to Assess the Pharmacokinetics of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR in Healthy Male Volunteers

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.

Inclusion Criteria:

• 19~50 years old, healthy male volunteers
• >55Kg(Body weight) and 18.5<BMI<28

Exclusion 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