GastritisPhase 1NCT07717775
A Study of Compare the Pharmacokinetic, Pharmacodynamic and Safety/Tolerability Characteristics Following Multiple Oral Administration of AD-234, AD-2341, and AD-2342 in Healthy Adults
A Phase 1 study testing AD-234, AD-2341 and AD-2342 in people with Gastritis, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-234, AD-2341, AD-2342 in healthy subjects. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastritis
- What is being tested?
- AD-234, AD-2341 and AD-2342
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2026to Nov 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers aged 19 to 50 years, inclusive, at the time of screening
- Body weight between 50.0 kg and 90.0 kg, inclusive, and body mass index (BMI) between 18.5 kg/m^2 and 29.9 kg/m^2, inclusive, at the time of screening (BMI = weight [kg] / height [m]^2)
- For female participants: not pregnant, not breastfeeding, or surgically sterile (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
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.
South Korea1 site
Seoul National University Hospital, Seoul,
Seoul
Seunghwan Lee
About this study
Official title: A Randomized, Open-label, 6-sequence, 3-period Crossover Clinical Trial to Compare the Pharmacokinetic, Pharmacodynamic and Safety/Tolerability Characteristics Following Multiple Oral Administration of AD-234, AD-2341, and AD-2342 in Healthy Adult Volunteers.
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-234, AD-2341, AD-2342 in healthy subjects.
Read the detailed description
The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-234 compared with AD-2341, AD-2342 in healthy subjects.
- Conditions
- Gastritis
- Being tested
- AD-234, AD-2341, AD-2342
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-234Drug
AD-234 tablet administered orally
AD-2341Drug
AD-2341 tablet administered orally
AD-2342Drug
AD-2342 tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Arm A(Vonoprazan, Fexuprazan, Vonoprazan) | Experimental | Participants receive AD-234 - AD-2341-AD-2342 Receives: Drug: AD-234; Drug: AD-2341; Drug: AD-2342 |
| Arm B(Vonoprazan, Vonoprazan, Fexuprazan) | Experimental | Participants receive AD-234 - AD-2342- AD-2341 Receives: Drug: AD-234; Drug: AD-2341; Drug: AD-2342 |
| Arm C(Fexuprazan, Vonoprazan, Vonoprazan) | Experimental | Participants receive AD-2341-AD-234-AD-2342 Receives: Drug: AD-234; Drug: AD-2341; Drug: AD-2342 |
| Arm D(Fexuprazan, Vonoprazan, Vonoprazan) | Experimental | Participants receive AD-2341-AD-2342-AD-234 Receives: Drug: AD-234; Drug: AD-2341; Drug: AD-2342 |
| Arm E(Vonoprazan, Vonoprazan, Fexuprazan) | Experimental | Participants receive AD-2342 -AD-234-AD-2341 Receives: Drug: AD-234; Drug: AD-2341; Drug: AD-2342 |
| Arm F(Vonoprazan, Fexuprazan, Vonoprazan) | Experimental | Participants receive AD-2342-AD-2341-AD-234 Receives: Drug: AD-234; Drug: AD-2341; Drug: AD-2342 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Time With Gastric pH ≥4 During the 24-hour Interval After the 7th Dose
Measured: From pre-dose (0h) on Day 7 to 24 hours post-dose on Day 7 of each treatment period (Period 1: Day 7-Day 8; Period 2: Day 28-Day 29; Period 3: Day 49-Day 50)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 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
- 30 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
- NCT07717775
- Sponsor's protocol ID
- AD-234PK/PD
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, 6-sequence, 3-period Crossover Clinical Trial to Compare the Pharmacokinetic, Pharmacodynamic and Safety/Tolerability Characteristics Following Multiple Oral Administration of AD-234, AD-2341, and AD-2342 in Healthy Adult Volunteers.
- ClinicalTrials.gov ID
- NCT07717775
- Acronym / sponsor ID
- AD-234PK/PD
- Conditions
- Gastritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Jul 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.
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-234, AD-2341, AD-2342 in healthy subjects.
Detailed description
The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-234 compared with AD-2341, AD-2342 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm A(Vonoprazan, Fexuprazan, Vonoprazan) | Experimental | Drug: AD-234, Drug: AD-2341, Drug: AD-2342Participants receive AD-234 - AD-2341-AD-2342 |
| Arm B(Vonoprazan, Vonoprazan, Fexuprazan) | Experimental | Drug: AD-234, Drug: AD-2341, Drug: AD-2342Participants receive AD-234 - AD-2342- AD-2341 |
| Arm C(Fexuprazan, Vonoprazan, Vonoprazan) | Experimental | Drug: AD-234, Drug: AD-2341, Drug: AD-2342Participants receive AD-2341-AD-234-AD-2342 |
| Arm D(Fexuprazan, Vonoprazan, Vonoprazan) | Experimental | Drug: AD-234, Drug: AD-2341, Drug: AD-2342Participants receive AD-2341-AD-2342-AD-234 |
| Arm E(Vonoprazan, Vonoprazan, Fexuprazan) | Experimental | Drug: AD-234, Drug: AD-2341, Drug: AD-2342Participants receive AD-2342 -AD-234-AD-2341 |
| Arm F(Vonoprazan, Fexuprazan, Vonoprazan) | Experimental | Drug: AD-234, Drug: AD-2341, Drug: AD-2342Participants receive AD-2342-AD-2341-AD-234 |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult volunteers aged 19 to 50 years, inclusive, at the time of screening
Key exclusion criteria (1 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-234AD-234 tablet administered orally | Drug | Arm A(Vonoprazan, Fexuprazan, Vonoprazan), Arm B(Vonoprazan, Vonoprazan, Fexuprazan), Arm C(Fexuprazan, Vonoprazan, Vonoprazan), Arm D(Fexuprazan, Vonoprazan, Vonoprazan), Arm E(Vonoprazan, Vonoprazan, Fexuprazan), Arm F(Vonoprazan, Fexuprazan, Vonoprazan) |
| AD-2341AD-2341 tablet administered orally | Drug | Arm A(Vonoprazan, Fexuprazan, Vonoprazan), Arm B(Vonoprazan, Vonoprazan, Fexuprazan), Arm C(Fexuprazan, Vonoprazan, Vonoprazan), Arm D(Fexuprazan, Vonoprazan, Vonoprazan), Arm E(Vonoprazan, Vonoprazan, Fexuprazan), Arm F(Vonoprazan, Fexuprazan, Vonoprazan) |
| AD-2342AD-2342 tablet administered orally | Drug | Arm A(Vonoprazan, Fexuprazan, Vonoprazan), Arm B(Vonoprazan, Vonoprazan, Fexuprazan), Arm C(Fexuprazan, Vonoprazan, Vonoprazan), Arm D(Fexuprazan, Vonoprazan, Vonoprazan), Arm E(Vonoprazan, Vonoprazan, Fexuprazan), Arm F(Vonoprazan, Fexuprazan, Vonoprazan) |
Primary outcome
Percent of Time With Gastric pH ≥4 During the 24-hour Interval After the 7th Dose
Time frame: From pre-dose (0h) on Day 7 to 24 hours post-dose on Day 7 of each treatment period (Period 1: Day 7-Day 8; Period 2: Day 28-Day 29; Period 3: Day 49-Day 50)
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 Jul 2026.
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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-234, AD-2341 and AD-2342 in people with Gastritis, 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 3 inclusion and 1 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 Jul 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?
Percent of Time With Gastric pH ≥4 During the 24-hour Interval After the 7th Dose (time frame: From pre-dose (0h) on Day 7 to 24 hours post-dose on Day 7 of each treatment period (Period 1: Day 7-Day 8; Period 2: Day 28-Day 29; Period 3: Day 49-Day 50)). 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 Jul 2026.