HypertensionPhase 1NCT02988362
Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)
A Phase 1 study testing HL068 16/10mg and Candesartan 16mg and Amlodipine 10mg in people with Hypertension, run by HanAll BioPharma Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- HL068 16/10mg and Candesartan 16mg and Amlodipine 10mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2016to 4 Feb 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
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.
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
- Being tested
- HL068 16/10mg, Candesartan 16mg and Amlodipine 10mg
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL068 16/10mgDrug
Candesartan 16mg and Amlodipine 10mg
Candesartan 16mg and Amlodipine 10mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Candesartan 16mg and Amlodipine 10mg | Experimental | Candesartan 16mg and Amlodipine 10mg Receives: Drug: Candesartan 16mg and Amlodipine 10mg |
| HL068 | Experimental | HL068(combination of Candesartan 16 mg and Amlodipine 10 mg) Receives: Drug: HL068 16/10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Measured: up to 72 hours
Cmax
Measured: up to 72 hours
Secondary outcomes (4)
AUCinf
Measured: up to 72 hours
Tmax
Measured: up to 72 hours
t 1/2β
Measured: up to 72 hours
CL/F
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start14 Dec 2016
- Primary completion4 Feb 2017
- Study completion4 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- HanAll BioPharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young-Ran Yoon, M.D, Ph.D, Principal investigator, KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL CLINICAL TRIAL CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988362
- Sponsor's protocol ID
- HL068
- Status last verified
- Apr 2025
- First submitted
- 7 Dec 2016
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02988362
- Acronym / sponsor ID
- HL068
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- HanAll BioPharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2016 (actual)
- Primary completion
- 4 Feb 2017 (actual)
- Study completion
- 4 Feb 2017 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candesartan 16mg and Amlodipine 10mg | Experimental | Drug: Candesartan 16mg and Amlodipine 10mgCandesartan 16mg and Amlodipine 10mg |
| HL068 | Experimental | Drug: HL068 16/10mgHL068(combination of Candesartan 16 mg and Amlodipine 10 mg) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HL068 16/10mgCandesartan 16mg and Amlodipine 10mg | Drug | HL068 |
| Candesartan 16mg and Amlodipine 10mg | Drug | Candesartan 16mg and Amlodipine 10mg |
Primary outcome
AUCt
Time frame: up to 72 hours
Cmax
Time frame: up to 72 hours
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Derived from this study: PubMed 32656160Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Ran Yoon, M.D, Ph.D principal investigator
KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL CLINICAL TRIAL CENTER
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HL068 16/10mg and Candesartan 16mg and Amlodipine 10mg in people with Hypertension, run by HanAll BioPharma Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt (time frame: up to 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02988362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.