A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-120 and AD-120A

NCT ID: NCT06916130

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-21

Study Completion Date

2025-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-120 in healthy subjects.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-120 compared with AD-120A in healthy subjects.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastroesophageal Reflux Disease (GERD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm-A

Period 1 : Test Drug (AD-120), Period 2 : Reference Drug (AD-120A)

Group Type EXPERIMENTAL

AD-120A

Intervention Type DRUG

Administered before the breakfast during 7 days, Oral, Tablet

AD-120

Intervention Type DRUG

Administered before the breakfast during 7 days, Oral, Tablet

Arm-B

Period 1 : Reference Drug (AD-120A), Period 2 : Test Drug (AD-120)

Group Type EXPERIMENTAL

AD-120A

Intervention Type DRUG

Administered before the breakfast during 7 days, Oral, Tablet

AD-120

Intervention Type DRUG

Administered before the breakfast during 7 days, Oral, Tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AD-120A

Administered before the breakfast during 7 days, Oral, Tablet

Intervention Type DRUG

AD-120

Administered before the breakfast during 7 days, Oral, Tablet

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Reference Drug Test drug

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Body weight equal to or greater than 50.0kg and equal to or less than 90.0kg and 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 and equal to or less than 50 in healthy volunteers at the time of screening visit
* Negative result from Serum Helicobacter pylori antibody at the time of screening visit

Exclusion Criteria

* Patients with trouble performing pH monitor catheter
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hanna Yang

Role: CONTACT

+82-31-891-6918

Seung Hwan Lee, M.D., Ph.D.

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Seunghwan Lee Lee, M.D.,PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AD-120PK/PD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.