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Completed

NCT Number: NCT02548286

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

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.

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Key information

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chungnam National University Hospital

Daejeon, Jung-gu, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male volunteer in the age of 19-45
  • Body weight ≥ 55 kg and in the range of calculated IBW ±20%
  • Subject without a hereditary problems, chronic disease and morbid symptom
  • Suitable clinical laboratory test values
  • Subject who sign on an informed consent form willingly

Exclusion criteria

  • Clinically significant disease with hepatobiliary, nephrological, neurologic, respiratory, haemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
  • Gastrointestinal disease or gastrointestinal surgery
  • History of significant hypersensitivity reaction of amlodipine, candesartan, calcium channel blocker, angiotensin II receptor blocker or other drugs
  • Galactose intolerance
  • Sitting systolic blood pressure ≥ 140 mmHg or< 90 mmHg, sitting diastolic blood pressure ≥ 95 mmHg or < 60 mmHg, pulse ≥ 100 beats per minute
  • Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin > 2 x upper limit of normal range
  • Serum Creatinine > upper limit of normal range
  • Drug abuse
  • Subject treated metabolizing enzyme inducers or inhibitors within 1 month
  • Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week
  • Subject treated Investigational product(include Bioequivalence test) within 3 months
  • Whole blood donation within 2 months, component blood donation or blood transfusion within 1 month
  • Continuously taking Alcohol > 21 units/week
  • Cigarette > 10 cigarettes/day
  • Subjects with planning of dental treatment or any surgery
  • Another clinical condition in judgement of investigator

Treatment and study plan

Candesartan 8mg

Drug

PO, 1day or 22day

Amlodipine 5mg

Drug

PO, 1day or 22day

CKD-330 8/5mg

Drug

PO, 1day or 22day

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

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)

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 14, 2015
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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