A Clinical Trial to Assess the Pharmacokinetics and Safety of AD-229 Compared to AD-2291 in Healthy Adults

February 26, 2026 updated by: Addpharma Inc.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A
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-229
AD-229 Oral Tablet
Drug: AD-2291
AD-2291 Oral Tablet
Experimental: Sequence B
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-229
AD-229 Oral Tablet
Drug: AD-2291
AD-2291 Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum concentration of drug in plasma (Cmax)
Time Frame: pre-dose (0hour) to 72hours
Cmax of AD-229
pre-dose (0hour) to 72hours
Area under the plasma concentration-time curve during dosing interval (AUCt)
Time Frame: pre-dose (0hour) to 72hours
AUCt of AD-229
pre-dose (0hour) to 72hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addpharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-229BE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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