GastritisPhase 1NCT07385248
A Clinical Trial to Assess the Pharmacokinetics and Safety of AD-229 Compared to AD-2291 in Healthy Adults
A Phase 1 study testing AD-229 and AD-2291 in people with Gastritis, run by Addpharma Inc..
Trial summary
The study compare and evaluate the safety and pharmacokinetic characteristics between the administration of AD-229 and the administration of AD-2291 in healthy adults. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastritis
- What is being tested?
- AD-229 and AD-2291
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at the time of screening visit
- The Age equal to or greater than 19 in healthy volunteers at the time of 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
About this study
Official title: An Open-label, Randomized, 2-treatment, 2-sequence, 2-period, Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of AD-229 and the Administration of AD-2291 for Healthy Adults in Fasting State
The study compare and evaluate the safety and pharmacokinetic characteristics between the administration of AD-229 and the administration of AD-2291 in healthy adults.
- Conditions
- Gastritis
- Being tested
- AD-229, AD-2291
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-229Drug
AD-229 Oral Tablet
AD-2291Drug
AD-2291 Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Single-dose oral administration of AD-2291 (Rebamipide 100mg) in Period 1, followed by single-dose oral administration of AD-229 (Rebamipide 300mg) in Period 2. Receives: Drug: AD-229; Drug: AD-2291 |
| Sequence B | Experimental | Single-dose oral administration of AD-229 (Rebamipide 300mg) in Period 1, followed by single-dose oral administration of AD-2291 (Rebamipide 100mg) in Period 2. Receives: Drug: AD-229; Drug: AD-2291 |
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-229
Measured: pre-dose (0hour) to 72hours
Area under the plasma concentration-time curve during dosing interval (AUCt)
AUCt of AD-229
Measured: pre-dose (0hour) to 72hours
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 startApr 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies 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
- 28 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
- NCT07385248
- Sponsor's protocol ID
- AD-229BE
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 27 Feb 2026
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, 2-treatment, 2-sequence, 2-period, Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of AD-229 and the Administration of AD-2291 for Healthy Adults in Fasting State
- ClinicalTrials.gov ID
- NCT07385248
- Acronym / sponsor ID
- AD-229BE
- Conditions
- Gastritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 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 between the administration of AD-229 and the administration of AD-2291 in healthy adults.
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-229, Drug: AD-2291Single-dose oral administration of AD-2291 (Rebamipide 100mg) in Period 1, followed by single-dose oral administration of AD-229 (Rebamipide 300mg) in Period 2. |
| Sequence B | Experimental | Drug: AD-229, Drug: AD-2291Single-dose oral administration of AD-229 (Rebamipide 300mg) in Period 1, followed by single-dose oral administration of AD-2291 (Rebamipide 100mg) in Period 2. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at the time of screening visit
- The Age equal to or greater than 19 in healthy volunteers at the time of 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 |
|---|---|---|
| AD-229AD-229 Oral Tablet | Drug | Sequence A, Sequence B |
| AD-2291AD-2291 Oral Tablet | Drug | Sequence A, Sequence B |
Primary outcome
Maximum concentration of drug in plasma (Cmax)
Time frame: pre-dose (0hour) to 72hours
Cmax of AD-229
Area under the plasma concentration-time curve during dosing interval (AUCt)
Time frame: pre-dose (0hour) to 72hours
AUCt of AD-229
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 27 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AD-229 and AD-2291 in people with Gastritis, run by Addpharma Inc..
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 27 Feb 2026. 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?
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?
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?
Maximum concentration of drug in plasma (Cmax) (time frame: pre-dose (0hour) to 72hours). 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 27 Feb 2026.