Status:
COMPLETED
Bioequivalence Study (Candesartan 8 mg and Amlodipine 5 mg)
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Hypertension
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 8 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in h...
Eligibility Criteria
Inclusion
- Healthy male volunteer in the age between 20 and 45 years old.
- Body weight ≥ 55 kg and Body weight in the range of calculated IBW ±20%.
- Subjects without a hereditary problems and chronic disease.
- Subjects whose clinical laboratory test values are inside the accepted normal range.
- Understand the requirements of the study and voluntarily consent to participate in the study.
Exclusion
- Previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system.
- History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
- History of clinically significant allergies of amlodipine or candesartan or CCB or ARB or aspirin or antibiotic.
- Subjects with galactose intolerance.
- SBP ≥ 140 mmHg or\< 90 mmHg, DBP ≥ 95 mmHg or \< 60 mmHg, pulse ≥ 100 BPM.
- AST or ALT \> 2\*ULN, total bilirubin \> 2\*ULN
- Serum Creatinine \> ULN
- Previous history or present of drug abuse.
- Subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1 month prior to the first dosing.
- Subjects treated ethical drug or herbal medicine within 2 weeks, OTC or vitamin within 1 week prior to the first dosing.
- Subjects treated IP within 2 months prior to the first dosing.
- Subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing.
- Alcohol \> 21 units/week or cannot stop drinking.
- Cigarette \> 10 cigarettes/day.
- Subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or any surgery(plastic surgery, eye surgery - LASIK, LASEK).
- Not eligible to participate for the study at the discretion of investigator.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02186496
Start Date
July 1 2014
End Date
November 1 2014
Last Update
December 2 2014
Active Locations (1)
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1
Chungnam National University Hospital
Daejeon, North Chungcheong, South Korea, 301-721