None listed
Conditions
Interventions
Drug : 1. Group A
- Period 1: Candesartan 8 mg 1T + Amlodipine 5 mg 1T
- Wash-out period: 21days
- Period 2: CKD-330 8/5mg 1T
2. Group B
- Period 1: CKD-330 8/5mg 1T
- Wash-out period:
Sponsors
Chong Kun Dang
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Healthy male volunteer in the age between 20 and 45 years old. 2.Body weight = 55 kg and Body weight in the range of calculated IBW ±20%. 3.Subjects without a hereditary problems and chronic disease. 4.Subjects whose clinical laboratory test values are inside the accepted normal range. 5.Understand the requirements of the study and voluntarily consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system. 2.History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption. 3.History of clinically significant allergies of amlodipine or candesartan or calcium channel blocker or angiotensin II receptor blocker or aspirin or antibiotic. 4.Subjects with galactose intolerance. 5.Systolic Blood Pressure = 140 mmHg or 2*upper limits of normal, total bilirubin > 2*upper limits of normal 7.Serum Creatinine > upper limits of normal 8.Previous history or present of drug abuse. 9.Subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1 month prior to the first dosing. 10.Subjects treated ethical drug or herbal medicine within 2 weeks, Over-The-Counter drug or vitamin within 1 week prior to the first dosing. 11.Subjects treated Investigational Product within 2 months prior to the first dosing. 12.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. 13.Alcohol > 21 units/week or cannot stop drinking. 14.Cigarette > 10 cigarettes/day. 15.Subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or any surgery(plastic surgery, eye surgery - LASIK, LASEK). 16.Not eligible to participate for the study at the discretion of investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt, Cmax of Candesartan;AUCt, Cmax, Amlodipine | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf, tmax, t1/2ß, CL/F of Candesartan;AUCinf, tmax, t1/2ß, CL/F of Amlodipine | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Kim
Chungnam National University Hospital
Outcome results
None listed