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Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)

Sponsor
HanAll BioPharma Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02988362
Collaborator
(none)
40
Enrollment
2
Arms
3
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: HL068 16/10mg
  • Drug: Candesartan 16mg and Amlodipine 10mg
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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 Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Feb 1, 2017
Anticipated Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Candesartan 16mg and Amlodipine 10mg

Candesartan 16mg and Amlodipine 10mg

Drug: Candesartan 16mg and Amlodipine 10mg
Experimental: HL068

HL068(combination of Candesartan 16 mg and Amlodipine 10 mg)

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

Outcome Measures

Primary Outcome Measures

  1. AUCt [up to 72 hours]

  2. Cmax [up to 72 hours]

Secondary Outcome Measures

  1. AUCinf [up to 72 hours]

  2. Tmax [up to 72 hours]

  3. t 1/2β [up to 72 hours]

  4. CL/F [up to 72 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • HanAll BioPharma Co., Ltd.

Investigators

  • Principal Investigator: Young-Ran Yoon, M.D, Ph.D, KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL CLINICAL TRIAL CENTER

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02988362
Other Study ID Numbers:
  • HL068
First Posted:
Dec 9, 2016
Last Update Posted:
Dec 9, 2016
Last Verified:
Dec 1, 2016
Additional relevant MeSH terms:
Hypertension
Amlodipine
Candesartan

Study Results

No Results Posted as of Dec 9, 2016