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

Overview

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.

Full Title of Study: “A Randomized, Open-label, Single-dosing, Crossover Study 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(B)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2015

Interventions

  • Drug: Candesartan 8mg
    • PO, 1day or 22day
  • Drug: Amlodipine 5mg
    • PO, 1day or 22day
  • Drug: CKD-330 8/5mg
    • PO, 1day or 22day

Arms, Groups and Cohorts

  • Active Comparator: Candesartan and Amlodipine
    • Candesartan 8mg and Amlodipine 5mg, PO, 1day or 22day
  • Experimental: CKD-330
    • CKD-330 8/5mg, PO, 1day or 22day

Clinical Trial Outcome Measures

Primary Measures

  • Cmax(Maximum Plasma Concentration) of Candesartan
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr

Secondary Measures

  • AUCinf(Area Under the Plasma Concentration-time curve from time t to infinity) of Candesartan
    • Time Frame: 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 Candesartan
    • Time Frame: 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
    • Time Frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
  • CL/F(Clearance/Bioavailability) of Candesartan
    • Time Frame: 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
    • Time Frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
  • tmax(Time to reach the maximum concentration) of Amlodipine
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 19 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Chong Kun Dang Pharmaceutical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jang Hee Hong, MD, PhD, Principal Investigator, Chungnam National University Hospital

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