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Not yet recruiting NCT06916130

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

Phase I Interventional Gastroesophageal Reflux Disease (GERD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AD-120A, AD-120.
Who it may be relevant to
Registry conditions: Gastroesophageal Reflux Disease (GERD). Basic parameters: 19 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Detailed description

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.

Interventions

  • Drug AD-120A
    Administered before the breakfast during 7 days, Oral, Tablet
  • Drug AD-120
    Administered before the breakfast during 7 days, Oral, Tablet

Primary outcome measures

  • 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)]
  • The time of peak concentration after single dose [Time frame: Tmax: from pre-dose to 24 hours of 1st administration]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT06916130 · AD-120PK/PD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗