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Bioequivalence Study (Candesartan 16 mg and Amlodipine 5 mg) - B

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ClinicalTrials.gov Identifier: NCT02811731
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
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 16 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.

Condition or disease Intervention/treatment Phase
Hypertension Drug: CKD-330 16/5mg - B Drug: Candesartan 16mg and Amlodipine 5mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-330(Fixed-dose Combination of Candesartan 16 mg and Amlodipine 5 mg) With Coadministration of the Two Separate Drugs in Healthy Male Volunteers (B)
Study Start Date : April 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Candesartan and Amlodipine
Candesartan 16mg and Amlodipine 5mg, PO, 1days or 22days
Drug: Candesartan 16mg and Amlodipine 5mg
Experimental: CKD-330
CKD-330 16/5mg - B, PO, 1days or 22days
Drug: CKD-330 16/5mg - B



Primary Outcome Measures :
  1. AUCt [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr ]

    A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr

    B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr


  2. Cmax [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr ]

    A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr

    B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr



Secondary Outcome Measures :
  1. AUCinf [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr ]

    A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr

    B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr


  2. tmax [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr ]

    A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr

    B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr


  3. t1/2β [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr ]

    A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr

    B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr


  4. CL/F [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr ]

    A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr

    B. Amlodipine: 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 between 19 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:

  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 CCB or ARB or aspirin or antibiotic.
  4. Subjects with galactose intolerance.
  5. SBP ≥ 140 mmHg or< 90 mmHg, DBP ≥ 95 mmHg or < 60 mmHg, pulse ≥ 100 BPM.
  6. AST or ALT > 2*ULN, total bilirubin > 2*ULN
  7. Serum Creatinine > ULN
  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, OTC or vitamin within 1 week prior to the first dosing.
  11. Subjects treated IP 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.

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): NCT02811731


Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Jang Hee Hong Chungnam National University Hospital
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02811731    
Other Study ID Numbers: 144BE15006
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
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