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Pharmacokinetics and Safety Evaluation of AD-229 and AD-2291 in Healthy Adults

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Study Aim

This study aims to evaluate the safety and how your body processes a new drug called AD-229 and AD-2291 in healthy adults.

What is being tested

AD-229

+ AD-2291

Drug
Who is being recruted

Digestive System Diseases+2

+ Gastritis

+ Gastroenteritis

Over 19 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2026
See protocol details

Summary

Principal SponsorAddpharma Inc.
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2026

Actual date on which the first participant was enrolled.

This is a study that focuses on comparing the safety and how the body processes two different forms of a drug, AD-229 and AD-2291, in healthy adults. The goal is to understand the differences between these two forms. This research is important as it helps to determine the most effective and safest way to administer the drug, which could potentially benefit future patients who need this treatment. During the study, participants receive both AD-229 and AD-2291 in separate periods. The order of receiving these forms is random and varies among participants. The study measures the amount of drug in the bloodstream at different time points, specifically looking at the maximum concentration of the drug (Cmax) and the area under the plasma concentration-time curve during the dosing interval (AUCt). These measurements help researchers understand how the body absorbs and eliminates each form of the drug.

Official TitleAn 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
NCT07385248
Principal SponsorAddpharma Inc.
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastritisGastroenteritisGastrointestinal DiseasesStomach Diseases

Criteria

2 inclusion criteria required to participate
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
2 exclusion criteria prevent from participating
Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
Other exclusions applied

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
In this group, participants will first receive the reference drug AD-2291, followed by the test drug AD-229.

Group II

Experimental
In this group, participants first receive the test drug AD-229, followed by the reference drug AD-2291.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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Recruiting soonNo study centers