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CompletedNCT02988362Updated Apr 4, 2025

Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)

A Phase 1 interventional study of HL068 16/10mg and Candesartan 16mg and Amlodipine 10mg in Hypertension, sponsored by HanAll BioPharma Co., Ltd.. Completed. Open to male participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by HanAll BioPharma Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 42 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

HanAll BioPharma Co., Ltd. is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • 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

Interventions

  • DrugHL068 16/10mg

    Candesartan 16mg and Amlodipine 10mg

  • DrugCandesartan 16mg and Amlodipine 10mg
06

What researchers measure

Primary outcomes

  1. AUCt

    Time frame: up to 72 hours

  2. Cmax

    Time frame: up to 72 hours

Secondary outcomes

  1. AUCinf

    Time frame: up to 72 hours

  2. Tmax

    Time frame: up to 72 hours

  3. t 1/2β

    Time frame: up to 72 hours

  4. CL/F

    Time frame: up to 72 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 32656160 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02988362
Lead sponsor
HanAll BioPharma Co., Ltd.
Responsible party
Sponsor
First posted
Dec 9, 2016
Start date
Dec 14, 2016
Primary completion
Feb 4, 2017
Completion
Feb 4, 2017
Last update
Apr 4, 2025

Study contacts

Young-Ran Yoon, M.D, Ph.D
principal investigator · KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL CLINICAL TRIAL CENTER

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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