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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

Phase : Phase I

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

Details

• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.
• Treatments: Amlodipine; Amlodipine, Valsartan Drug Combination

Criteria

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