Single-dose safety and blood-level comparison of AD-115A versus AD-1151 in healthy adults
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
Run by Addpharma Inc. · NCT07385235 · Data updated 2026-11-12
This test will see if a single dose of AD-115A or AD-1151 is safe and how each drug is absorbed and cleared in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Addpharma Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | January 27, 2026 |
| Main results expected | March 7, 2026 |
| Study ends | March 16, 2026 |
| Registry record updated | February 11, 2026 |
| Trial ID | NCT07385235 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 19 years or older with a BMI between 18.0 and 30.0 kg/m2 who can stop interfering medications before dosing are the intended participants.
✕Probably not a fit
People with active gastric disease requiring treatment, those taking enzyme-inducing or -inhibiting drugs within the specified washout periods, or those who do not meet the health/BMI criteria are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, open-label, single-dose, two-sequence, two-period crossover PK and safety comparison of AD-115A and AD-1151 in fasting healthy adults. Each participant receives both formulations in separate periods to compare blood concentrations over time and monitor adverse events. Key measurements include pharmacokinetic parameters (e.g., Cmax, AUC) and safety labs, vital signs, and adverse event reporting. Eligible volunteers are adults aged 19 or older with BMI 18.0–30.0 kg/m2 and no recent use of drugs that affect drug metabolism.
Why it matters
Potential benefit: If results show comparable safety and favorable pharmacokinetics, the findings could help pick the better formulation and guide dose decisions for future ulcer treatment development.
How similar studies have gone: PK and safety crossover comparisons of similar paired formulations are common and have sometimes shown equivalent PK, but this specific AD-115A versus AD-1151 comparison appears novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
H PLUS YANGJI HOSPITAL, Seoul
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: JaeHun Jung
- Email: jhjung@addpharma.co.kr
- Phone: +82-31-891-5683
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.