NCT07385248

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
1mo left

Started Apr 2026

Shorter than P25 for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

January 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

January 27, 2026

Last Update Submit

February 26, 2026

Conditions

Gastritis

Outcome Measures

Primary Outcomes (2)

  • Maximum concentration of drug in plasma (Cmax)

    Cmax of AD-229

    pre-dose (0hour) to 72hours

  • Area under the plasma concentration-time curve during dosing interval (AUCt)

    AUCt of AD-229

    pre-dose (0hour) to 72hours

Study Arms (2)

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.

Drug: AD-229Drug: 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.

Drug: AD-229Drug: AD-2291

Interventions

AD-229DRUG

AD-229 Oral Tablet

Sequence ASequence B
AD-2291DRUG

AD-2291 Oral Tablet

Sequence ASequence B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastritis

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 4, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share