Hypertension
Conditions
Keywords
Hypertension, Healthy male volunteer, Candesartan, Amlodipine
Brief summary
The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.
Interventions
DRUGCandesartan 8mg
PO, 1day or 22day
DRUGAmlodipine 5mg
PO, 1day or 22day
DRUGCKD-330 8/5mg
PO, 1day or 22day
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male volunteer in the age of 19-45 2. Body weight ≥ 55 kg and in the range of calculated IBW ±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
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 |
|---|---|
| Cmax(Maximum Plasma Concentration) of Candesartan | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr |
| AUCt(Area Under the Plasma Concentration-time curve) of Candesartan | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr |
| Cmax(Maximum Plasma Concentration) of Amlodipine | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
| AUCt(Area Under the Plasma Concentration-time curve) of Amlodipine | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
Secondary
| Measure | Time frame |
|---|---|
| tmax(Time to reach the maximum concentration) of Candesartan | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr |
| t1/2β(Time for C max to drop in half) of Candesartan | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr |
| AUCinf(Area Under the Plasma Concentration-time curve from time t to infinity) of Amlodipine | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
| CL/F(Clearance/Bioavailability) of Amlodipine | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
| CL/F(Clearance/Bioavailability) of Candesartan | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr |
| tmax(Time to reach the maximum concentration) of Amlodipine | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
| t1/2β(Time for C max to drop in half) of Amlodipine | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
| AUCinf(Area Under the Plasma Concentration-time curve from time t to infinity) of Candesartan | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr |
Countries
South Korea
Outcome results
None listed