None listed
Conditions
Interventions
Drug : 1. Arm A
(1) Phase 1: Candesartan 8mg and Amlodipine 5mg, PO,1 day administration
(2) Phase 2: CKD-330 8/5mg, PO, 22 day administration
2. Arm B
(1) Phase 1: CKD-330 8/5mg, PO,1 day a
Sponsors
Chungnam National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male volunteer in the age of 19-45 2. Body weight = 55 kg and in the range of calculated IBW(Ideal Body Weight) ±20% 3. Subject without a hereditary problems, chronic disease and morbid symptom 4. Suitable clinical laboratory test values 5. Subject who sign on an informed consent form willingly
Exclusion criteria
Exclusion criteria: 1. Clinically significant disease with hepatobiliary, nephrological, neurologic, respiratory, haemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system 2. Gastrointestinal disease or gastrointestinal surgery 3. History of significant hypersensitivity reaction of amlodipine, candesartan, calcium channel blocker, angiotensin II receptor blocker or other drugs 4. Galactose intolerance 5. Sitting systolic blood pressure = 140 mmHg or< 90 mmHg, sitting diastolic blood pressure = 95 mmHg or < 60 mmHg, pulse = 100 beats per minute 6. Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin > 2 x upper limit of normal range 7. Serum Creatinine > upper limit of normal range 8. Drug abuse 9. Subject treated metabolizing enzyme inducers or inhibitors within 1 month 10. Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week 11. Subject treated Investigational product(include Bioequivalence test) within 3 months 12. Whole blood donation within 2 months, component blood donation or blood transfusion within 1 month 13. Continuously taking Alcohol > 21 units/week 14. Cigarette > 10 cigarettes/day 15. Subjects with planning of dental treatment or any surgery 16. Another clinical condition in judgement of investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt, Cmax of Candesartan and Amlodipine | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf, tmax, t1/2ß, CL/F of Candesartan and Amlodipine;Safety | — |
Countries
Korea, Republic of
Contacts
Public ContactJang Hong
Chungnam National University Hospital
Outcome results
None listed