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
- Registration Number
- NCT01776047
- Lead Sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Brief Summary
Study Design : randomized, open label, single-dose, 2-way cross-over design
Phase : Phase I
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 51
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Exforge® 10/160 (Amlodipine besylate 10mg / Valsartan 160mg) Exforge® Exforge® 10/160 G-0081 (Amlodipine orotate 10mg / Valsratan 160mg) G-0081 G-0081
- Primary Outcome Measures
Name Time Method AUClast, Cmax Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h
- Secondary Outcome Measures
Name Time Method AUCinf, Tmax, t1/2, % AUCextra Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h AUCinf = AUClast + Clast/λz
%AUCextra = \[ (AUCinf - AUClast) / AUCinf \] ×100
t1/2 = 0.693/λz