Pharmacokinetic/Pharmacodynamic & Safety Study of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers
- Registration Number
- NCT02058472
- 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
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- healthy volunteers between the ages of 19 to 55 years old
- 19 ≤ BMI ≤ 27
- 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 olmesartan
- Exceed 1.5 times of the upper limit of the reference range of AST, ALT, total bilirubin, γ-GT
- Excessive drinking(exceed alcohol 140g/week)
- Excessive caffeine(exceed 4cups/day) and grape fruit/orange juice(exceed 1cup/day)
- Smoking over 10 cigarettes per day
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SEVIKAR® G3041 Amlodipine besylate 10mg/Olmesartan medoxomil 40mg G3041 G3041 Amlodipine orotate 10mg/Olmesartan medoxomil 40mg G3041 SEVIKAR® Amlodipine orotate 10mg/Olmesartan medoxomil 40mg SEVIKAR® SEVIKAR® Amlodipine besylate 10mg/Olmesartan medoxomil 40mg
- Primary Outcome Measures
Name Time Method AUClast, Cmax Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h
- Secondary Outcome Measures
Name Time Method ΔAUEC24, ΔEmax, tEmax 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h tmax, t1/2, AUCinf, CL/F, Vz/F Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h