HypertensionPhase 1NCT07312773
A Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-231A and AD-231B and AD-231C
A Phase 1 study testing Treatment A(AD-231A), Treatment B(AD-231B+AD-231C) and Treatment C(AD-231A+AD-231B+AD-231C) in people with Hypertension and Hyperlipidemia, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
To evaluate the pharmacokinetic interactions of AD-231A, AD-231B, and AD-231C in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Hyperlipidemia
- What is being tested?
- Treatment A(AD-231A), Treatment B(AD-231B+AD-231C) and Treatment C(AD-231A+AD-231B+AD-231C)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jan 2026to 22 Feb 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers aged ≥19 and <65 years at the time of the screening visit
- Body weight ≥50 kg (≥45 kg for females) and body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of the screening visit
Who cannot join
- Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
- Other exclusions applied
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Two-arm, Open-label, Single-sequence, Multiple-dose Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-231A and AD-231B and AD-231C in Healthy Adult Volunteers
To evaluate the pharmacokinetic interactions of AD-231A, AD-231B, and AD-231C in healthy adult volunteers.
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- Treatment A(AD-231A), Treatment B(AD-231B+AD-231C), Treatment C(AD-231A+AD-231B+AD-231C)
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A(AD-231A)Drug
AD-231A Oral Tablet
Treatment B(AD-231B+AD-231C)Drug
AD-231B+AD-231C Oral Tablet
Treatment C(AD-231A+AD-231B+AD-231C)Drug
AD-231A+AD-231B+AD-231C Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Period 1 : Treatment A(AD-231A), Period 2 : Treatment C(AD-231A+AD-231B+AD-231C) Receives: Drug: Treatment A(AD-231A); Drug: Treatment C(AD-231A+AD-231B+AD-231C) |
| Arm B | Experimental | Period 1 : Treatment B(AD-231B+AD-231C), Period 2 : Treatment C(AD-231A+AD-231B+AD-231C) Receives: Drug: Treatment B(AD-231B+AD-231C); Drug: Treatment C(AD-231A+AD-231B+AD-231C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss)
AUCτ,ss
Measured: pre-dose (0hour) to 24 hours post-dose on Day 14
Maximum concentration of drug in plasma at steady state (Cmax,ss)
Measured: pre-dose (0hour) to 24 hours post-dose on Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start23 Jan 2026 (estimated)
- Primary completion7 Feb 2026 (estimated)
- Study completion22 Feb 2026 (estimated)
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.
- More trials run by Addpharma Inc.The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312773
- Sponsor's protocol ID
- AD-231DDI
- Status last verified
- Nov 2025
- First submitted
- 17 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-arm, Open-label, Single-sequence, Multiple-dose Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-231A and AD-231B and AD-231C in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07312773
- Acronym / sponsor ID
- AD-231DDI
- Conditions
- Hypertension, Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2026 (estimated)
- Primary completion
- 7 Feb 2026 (estimated)
- Study completion
- 22 Feb 2026 (estimated)
- First posted
- 31 Dec 2025 (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.
To evaluate the pharmacokinetic interactions of AD-231A, AD-231B, and AD-231C in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Treatment A(AD-231A), Drug: Treatment C(AD-231A+AD-231B+AD-231C)Period 1 : Treatment A(AD-231A), Period 2 : Treatment C(AD-231A+AD-231B+AD-231C) |
| Arm B | Experimental | Drug: Treatment B(AD-231B+AD-231C), Drug: Treatment C(AD-231A+AD-231B+AD-231C)Period 1 : Treatment B(AD-231B+AD-231C), Period 2 : Treatment C(AD-231A+AD-231B+AD-231C) |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult volunteers aged ≥19 and <65 years at the time of the screening visit
- Body weight ≥50 kg (≥45 kg for females) and body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of the screening visit
Key exclusion criteria (2 listed)
- Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
- Other exclusions applied
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 |
|---|---|---|
| Treatment A(AD-231A)AD-231A Oral Tablet | Drug | Arm A |
| Treatment B(AD-231B+AD-231C)AD-231B+AD-231C Oral Tablet | Drug | Arm B |
| Treatment C(AD-231A+AD-231B+AD-231C)AD-231A+AD-231B+AD-231C Oral Tablet | Drug | Arm A, Arm B |
Primary outcome
Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss)
Time frame: pre-dose (0hour) to 24 hours post-dose on Day 14
AUCτ,ss
Maximum concentration of drug in plasma at steady state (Cmax,ss)
Time frame: pre-dose (0hour) to 24 hours post-dose on Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- 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.
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 Treatment A(AD-231A), Treatment B(AD-231B+AD-231C) and Treatment C(AD-231A+AD-231B+AD-231C) in people with Hypertension and Hyperlipidemia, run by Addpharma Inc. 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 31 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JaeHun Jung (+8247679615, jhjung@addpharma.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss) (time frame: pre-dose (0hour) to 24 hours post-dose on Day 14). 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?
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 31 Dec 2025.