Study to Compare the Safety and Pharmacokinetics of CKD-330 8/5mg With Coadministration of the Two Separate Drugs

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Amlodipine; Candesartan; Candesartan cilexetil

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 ±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