Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)

Overview

The purpose of this study is to compare the safety and pharmacokinetics of HL068 (Candesartan 16 mg and Amlodipine 10mg) with coadministration of the two separate drugs in healthy male volunteers.

Full Title of Study: “An Open-label, Randomized, Cross-over Study to Evaluate Pharmacokinetics and the Safety of HL068 16/10mg Compared to Candesartan 16mg and Amlodipine 10mg Co-administered in Healthy Male Volunteers.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2017

Interventions

  • Drug: HL068 16/10mg
    • Candesartan 16mg and Amlodipine 10mg
  • Drug: Candesartan 16mg and Amlodipine 10mg

Arms, Groups and Cohorts

  • Experimental: Candesartan 16mg and Amlodipine 10mg
    • Candesartan 16mg and Amlodipine 10mg
  • Experimental: HL068
    • HL068(combination of Candesartan 16 mg and Amlodipine 10 mg)

Clinical Trial Outcome Measures

Primary Measures

  • AUCt
    • Time Frame: up to 72 hours
  • Cmax
    • Time Frame: up to 72 hours

Secondary Measures

  • AUCinf
    • Time Frame: up to 72 hours
  • Tmax
    • Time Frame: up to 72 hours
  • t 1/2β
    • Time Frame: up to 72 hours
  • CL/F
    • Time Frame: up to 72 hours

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy male volunteer in the age between 19 and 55 years old. – Body mass index (BMI) in the range of 18.5 to 27.0 kg/m2 – Understand the requirements of the study and voluntarily consent to participate in the study. Exclusion Criteria:

  • Previous history or present of clinically significant digestive , cardiovascular, respiratory, psychiatric, endocrine, hepatobiliary, renal disease. – History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption. – Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. – Subjects whose clinical laboratory test values are outside the accepted normal range. Especially, ASTor ALT >1.5 times of the Upper Normal Limit or total bilirubin > 1.5 times of the Upper Normal Limit – Positive test results for Hepatitis B antibodies, Hepatitis C virus antibody, and Syphilis regain test – Participation in any clinical investigation within 3 months prior to study drug administration – Subjects with whole blood donation within 60 days or component blood donation within 30days or blood transfusion within 30days prior to the first dosing. – SBP ≥ 140 mmHg or< 115 mmHg, DBP ≥ 90 mmHg or < 70 mmHg – Caffeine > 400mg/day – Alcohol > 30g/day – Cigarette > 10 cigarettes/day. – Subjects who are judged unsuitable by investigators

Gender Eligibility: Male

Minimum Age: 19 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • HanAll BioPharma Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Young-Ran Yoon, M.D, Ph.D, Principal Investigator, KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL CLINICAL TRIAL CENTER

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