Gastric UlcerPhase 1NCT07385235
Compare and Evaluate the Safety and PK Data of a Single Dose Administration of 'AD-115A' or 'AD-1151'
A Phase 1 study testing AD-115A, AD-1151 in people with Gastric Ulcer, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
The study compare and evaluate the safety and pharmacokinetic characteristics of a single dose administration of 'AD-115A' or 'AD-1151' in healthy adults. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Ulcer
- What is being tested?
- AD-115A, AD-1151
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jan 2026to 16 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
- Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
Who cannot join
- Individuals who have taken drugs that induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 30 days prior to the start of the study (first dosing day), or have taken drugs that may affect this study within 10 days prior to the start of the study (first dosing day)
- 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.
South Korea1 site, 1 recruiting
- Recruiting
H PLUS YANGJI HOSPITAL, Seoul
Seoul
About this study
Official title: A Randomized, Open-label, Single-dose, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of AD-115A and the Administration of AD-1151 for Healthy Subjects in Fasting State
The study compare and evaluate the safety and pharmacokinetic characteristics of a single dose administration of 'AD-115A' or 'AD-1151' in healthy adults.
Read the detailed description
A randomized, open-label, single-dose, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of AD-115A and the administration of AD-1151 for healthy subjects in fasting state
- Conditions
- Gastric Ulcer
- Being tested
- AD-115A, AD-1151
- Medical subject headings
- Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-115A, AD-1151Drug
Single-dose oral administration of AD-115A or AD-1151 (200 mg tablet), according to randomized sequence.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Period 1 : Reference Drug(Rebanex Tab), Period 2 : Test Drug(Revaprazan sulfate)
Single-dose oral administration of AD-115A (200 mg tablet) in Period 1, followed by single-dose oral administration of AD-1151 (200 mg tablet) in Period 2. Receives: Drug: AD-115A, AD-1151 |
| Sequence B | Experimental | Period 1 : Test Drug(Revaprazan sulfate), Period 2 : Reference Drug(Rebanex Tab)
Single-dose oral administration of AD-115A (200 mg tablet) in Period 1, followed by single-dose oral administration of AD-1151 (200 mg tablet) in Period 2. Receives: Drug: AD-115A, AD-1151 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration of drug in plasma (Cmax)
Cmax of AD-115A
Measured: pre-dose to 24 hours
Area under the plasma concentration-time curve during dosing interval (AUCt)
AUCt of AD-115A
Measured: pre-dose to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start27 Jan 2026
- Primary completion7 Mar 2026 (estimated)
- Study completion16 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UlcerStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 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
- NCT07385235
- Sponsor's protocol ID
- AD-115BE-02
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of AD-115A and the Administration of AD-1151 for Healthy Subjects in Fasting State
- ClinicalTrials.gov ID
- NCT07385235
- Acronym / sponsor ID
- AD-115BE-02
- Conditions
- Gastric Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 7 Mar 2026 (estimated)
- Study completion
- 16 Mar 2026 (estimated)
- First posted
- 4 Feb 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.
The study compare and evaluate the safety and pharmacokinetic characteristics of a single dose administration of 'AD-115A' or 'AD-1151' in healthy adults.
Detailed description
A randomized, open-label, single-dose, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of AD-115A and the administration of AD-1151 for healthy subjects in fasting state
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: AD-115A, AD-1151Period 1 : Reference Drug(Rebanex Tab), Period 2 : Test Drug(Revaprazan sulfate) Single-dose oral administration of AD-115A (200 mg tablet) in Period 1, followed by single-dose oral administration of AD-1151 (200 mg tablet) in Period 2. |
| Sequence B | Experimental | Drug: AD-115A, AD-1151Period 1 : Test Drug(Revaprazan sulfate), Period 2 : Reference Drug(Rebanex Tab) Single-dose oral administration of AD-115A (200 mg tablet) in Period 1, followed by single-dose oral administration of AD-1151 (200 mg tablet) in Period 2. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
- Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
Key exclusion criteria (2 listed)
- Individuals who have taken drugs that induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 30 days prior to the start of the study (first dosing day), or have taken drugs that may affect this study within 10 days prior to the start of the study (first dosing day)
- 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 |
|---|---|---|
| AD-115A, AD-1151Single-dose oral administration of AD-115A or AD-1151 (200 mg tablet), according to randomized sequence. | Drug | Sequence A, Sequence B |
Primary outcome
Maximum concentration of drug in plasma (Cmax)
Time frame: pre-dose to 24 hours
Cmax of AD-115A
Area under the plasma concentration-time curve during dosing interval (AUCt)
Time frame: pre-dose to 24 hours
AUCt of AD-115A
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 11 Feb 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.
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 AD-115A, AD-1151 in people with Gastric Ulcer, 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: looking for participants now, as of the sponsor's last update on 11 Feb 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?
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 (+82-31-891-5683, jhjung@addpharma.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration of drug in plasma (Cmax) (time frame: pre-dose to 24 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?
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 11 Feb 2026.