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

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ClinicalTrials.gov Identifier: NCT02548286
Recruitment Status : Completed
First Posted : September 14, 2015
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Candesartan 8mg Drug: Amlodipine 5mg Drug: CKD-330 8/5mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Study Start Date : August 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Candesartan and Amlodipine
Candesartan 8mg and Amlodipine 5mg, PO, 1day or 22day
Drug: Candesartan 8mg
PO, 1day or 22day

Drug: Amlodipine 5mg
PO, 1day or 22day

Experimental: CKD-330
CKD-330 8/5mg, PO, 1day or 22day
Drug: CKD-330 8/5mg
PO, 1day or 22day




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548286


Locations
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Korea, Republic of
Chungnam National University Hospital
Daejeon, Jung-gu, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Jang Hee Hong, MD, PhD Chungnam National University Hospital
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02548286    
Other Study ID Numbers: 144BE15015
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015
Keywords provided by Chong Kun Dang Pharmaceutical:
Hypertension
Healthy male volunteer
Candesartan, Amlodipine
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Candesartan
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists