Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)

NCT02988362 | Completed Phase 1

• 1 other identifier: HL068
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• AUCt

  up to 72 hours

• Cmax

  up to 72 hours

Secondary Outcomes (4)

• AUCinf

  up to 72 hours

• Tmax

  up to 72 hours

• t 1/2β

  up to 72 hours

• CL/F

  up to 72 hours

Study Arms (2)

Candesartan 16mg and Amlodipine 10mg

EXPERIMENTAL

Candesartan 16mg and Amlodipine 10mg

Drug: Candesartan 16mg and Amlodipine 10mg

HL068

EXPERIMENTAL

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

Drug: HL068 16/10mg

Interventions

HL068 16/10mg DRUG

Candesartan 16mg and Amlodipine 10mg

HL068

Candesartan 16mg and Amlodipine 10mg DRUG

Candesartan 16mg and Amlodipine 10mg

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HanAll BioPharma Co., Ltd.: lead

Related Publications (1)

• Lee HW, Kang WY, Jung W, Gwon MR, Yang DH, Kim EH, Cho K, Yoon YR, Seong SJ. Pharmacokinetics and bioequivalence of fixed-dose combination of candesartan cilexetil/amlodipine besylate (16/10 mg) versus coadministration of individual formulations in healthy subjects. Transl Clin Pharmacol. 2020 Jun;28(2):92-101. doi: 10.12793/tcp.2020.28.e8. Epub 2020 Jun 24.

  PMID: 32656160 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

candesartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Young-Ran Yoon, M.D, Ph.D

  KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL CLINICAL TRIAL CENTER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 9, 2016
• Study Start: December 14, 2016
• Primary Completion: February 4, 2017
• Study Completion: February 4, 2017
• Last Updated: April 4, 2025

Record last verified: 2025-04