HypertensionPhase 1NCT07598968
Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of HL1113-R1 and HL1113-R2 in Healthy Adult Volunteers
A Phase 1 study testing Test group 1 and Test group 2 in people with Hypertension and Diabete Type 2, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
This clinical trial is a two-arm, open-label, single-sequence, multiple oral dosings, cross-over design clinical trial to evaluate the safety and pharmacokinetic characteristics of HL1113-R1 and HL1113-R2 in healthy adult volunteers Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Diabete Type 2
- What is being tested?
- Test group 1 and Test group 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jun 2023to 12 Jul 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy adult subjects aged ≥19 years at the time of screening
- Subjects with no clinically significant congenital or chronic diseases based on screening, and no clinically significant findings on internal medicine examination (including, if necessary, electroencephalogram [EEG], electrocardiogram [ECG], chest examination, upper gastrointestinal endoscopy, or gastrointestinal radiography)
- etc.
Who cannot join
- Subjects who have received medications known to markedly induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to the screening visit
- Subjects who have received any medications that may affect the outcome of the study within 10 days prior to the screening visit
- etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Cross-over Design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of HL1113-R1 and HL1113-R2 in Healthy Adult Volunteers
This clinical trial is a two-arm, open-label, single-sequence, multiple oral dosings, cross-over design clinical trial to evaluate the safety and pharmacokinetic characteristics of HL1113-R1 and HL1113-R2 in healthy adult volunteers
- Conditions
- Hypertension, Diabete Type 2
- Being tested
- Test group 1, Test group 2
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test group 1Drug
- Period 1: HL1113-R1, once daily, administered for 7 days
- Period 2: HL1113-R1 + HL1113-R2 once daily, administered for 7 days
Test group 2Drug
- Period 1: HL1113-R2, once daily, administered for 5 days
- Period 2: HL1113-R2 + HL1113-R1 once daily, administered for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Test group 1 | Experimental | Not described Receives: Drug: Test group 1 |
| Test group 2 | Experimental | Not described Receives: Drug: Test group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss
Measured: a steady state after 5~7 days of repeated administration
Secondary outcomes (1)
Tmax,ss
Measured: a steady state after 5~7 days of repeated administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start18 Jun 2023
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598968
- Sponsor's protocol ID
- HL1113-101
- Status last verified
- May 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Cross-over Design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of HL1113-R1 and HL1113-R2 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07598968
- Acronym / sponsor ID
- HL1113-101
- Conditions
- Hypertension, Diabete Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2023 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 20 May 2026 (actual)
- 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.
This clinical trial is a two-arm, open-label, single-sequence, multiple oral dosings, cross-over design clinical trial to evaluate the safety and pharmacokinetic characteristics of HL1113-R1 and HL1113-R2 in healthy adult volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group 1 | Experimental | Drug: Test group 1 |
| Test group 2 | Experimental | Drug: Test group 2 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult subjects aged ≥19 years at the time of screening
- Subjects with no clinically significant congenital or chronic diseases based on screening, and no clinically significant findings on internal medicine examination (including, if necessary, electroencephalogram [EEG], electrocardiogram [ECG], chest examination, upper gastrointestinal endoscopy, or gastrointestinal radiography)
- etc.
Key exclusion criteria (3 listed)
- Subjects who have received medications known to markedly induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to the screening visit
- Subjects who have received any medications that may affect the outcome of the study within 10 days prior to the screening visit
- etc.
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 |
|---|---|---|
| Test group 1* Period 1: HL1113-R1, once daily, administered for 7 days * Period 2: HL1113-R1 + HL1113-R2 once daily, administered for 7 days | Drug | Test group 1 |
| Test group 2* Period 1: HL1113-R2, once daily, administered for 5 days * Period 2: HL1113-R2 + HL1113-R1 once daily, administered for 7 days | Drug | Test group 2 |
Primary outcome
AUCτ,ss
Time frame: a steady state after 5~7 days of repeated administration
1 secondary outcome
Tmax,ss
Time frame: a steady state after 5~7 days of repeated administration
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 20 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test group 1 and Test group 2 in people with Hypertension and Diabete Type 2, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
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 3 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
AUCτ,ss (time frame: a steady state after 5~7 days of repeated administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2026.