A randomized, open-label, single-dosing, 2x2 crossover study 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 healthy male volunteers
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0001201
- Lead Sponsor
- Chong Kun Dang
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 32
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.
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< 90 mmHg, Diastolic Blood Pressure = 95 mmHg or < 60 mmHg, pulse = 100 beats per minute.
6.Aspartate Transaminase or Aspartate Transaminase > 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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCt, Cmax of Candesartan;AUCt, Cmax, Amlodipine
- Secondary Outcome Measures
Name Time Method AUCinf, tmax, t1/2ß, CL/F of Candesartan;AUCinf, tmax, t1/2ß, CL/F of Amlodipine