None listed
Conditions
Interventions
Drug : Reference drug: SEVIKAR tab. 10/40mg(olmesartan medoxomil 40mg/amlodipine besilate 13.87mg), 1 tab., single oral administration
Test drug : LODIVIKAR tab. 5/40mg(olmesartan medoxomil 40mg/S-am
Sponsors
Hanlim Pharmaceutical
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Years 20-45, healthy male 2) Body weight=55kg and IBW=± 20% 3) Subject judged suitable by physical examination and interview conducted in accordance with this study protocol 4) Subject judged suitable by clinical laboratory tests and ECG 5) volunteer
Exclusion criteria
Exclusion criteria: 1) Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease 2) Subject with known for hypersensitivity reaction to S-amlodipine, amlodipine and olmesartan and dihydropyridine derivatives 3) Clinically significant hypotension(SBP=100mmHg, DBP=60mmHg) or hypertension(SBP=150mmHg, DBP=95mmHg) when screening period 4) Subject with known for history of gastrointestinal disease or gastrointestinal surgery which affect on the absorption drug 5) Subject with any of the following conditions in laboratory test i. AST(sGOT) or ALT(sGPT) > Upper normal limit × 1.5 ii. Total bilirubin > Upper normal limit × 1.5 iii. reanl failure with Creatinine clearance five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette > 10 cigarettes per day) 7) Participation in any clinical investigation within 60days prior to study medication dosing 8) Subjects with whole blood donation within 60days, component blood donation within 30days 9) Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital wihin 28days prior to study medication dosing 10) Use of any prescription medication within 14 days prior to study medication dosing or use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing 11) psychiatric disorder, drug addiction 12) Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefluit juice within 14 days prior to study medication dosing 13) Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic evaluation(Cmax, AUCt) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability evaluation | — |
Countries
Korea, Republic of
Contacts
Public ContactAe Kim
Metro Hospital
Outcome results
None listed