A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers

A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers

Study Design : randomized, open label, single-dose, 2-way cross-over design

Phase : Phase I

Inclusion Criteria:

• healthy male volunteers between the ages of 20 to 50 years old within the range of ±20% of IBW(Ideal Body Weight)
• having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
• doctor determines to be suitable as subjects within 4 weeks ago before administration

Exclusion Criteria:

• Hypersensitivity(or history of hypersensitivity) to amlodipine and valsartan
• Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT
• Gastrointestinal diseases or surgeries that affect absorption of drug
• Excessive drinking(exceed 30g/week) and excessive caffeine(exceed 250mg/day)
• Smoking over 10 cigarettes per day