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NCT Number: NCT06916130

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

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

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Key information

Conditions

Gastroesophageal Reflux Disease (GERD) Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Location contact

Seunghwan Lee Lee, M.D.,PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AD-120A

Drug

Administered before the breakfast during 7 days, Oral, Tablet

Other names: Reference Drug

AD-120

Drug

Administered before the breakfast during 7 days, Oral, Tablet

Other names: Test drug

Primary outcomes

  1. Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)

    Time frame: AUCτ,ss: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)

    AUCτ,ss after 7days repeated administration of Omeprazole

  2. The time of peak concentration after single dose

    Time frame: Tmax: from pre-dose to 24 hours of 1st administration

    Tmax after 1days administration of Omeprazole

  3. Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring

    Time frame: 24 hours before 1st administration to 24 hours after repeated administration (7days)

    Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring for 24-hour interval after 7th dose

Study contacts

Contact information is provided by the study sponsor or research team.

Hanna Yang

CONTACT

[email protected]

+82-31-891-6918

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

CONTACT

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

A Randomized, Open-label, Multiple Oral-dose, 2x2 Crossover Clinical Trial to Compare the Safety, Pharmacokinetic, and Pharmacodynamic Characteristics of a AD-120 and AD-120A in Healthy Adult Volunteers

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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