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Not yet recruiting NCT07618845

A Clinical Trial to Assess the Pharmacokinetics, Safety, and Food Effect of AD-230 in Healthy Adults

Phase I Interventional Chronic Liver Disease (CLD)

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-230 (Fasted), AD-230 (Fed).
Who it may be relevant to
Registry conditions: Chronic Liver Disease (CLD). Basic parameters: 19 years — 64 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, 2-period, 2-sequence, Crossover Study to Evaluate the Food Effect on the Safety and the Pharmacokinetics of AD-230 in Healthy Adult Volunteers

Overview

A clinical trial to assess the pharmacokinetics, safety, and food effect of AD-230 in healthy adults

Interventions

  • Drug AD-230 (Fasted)
    AD-230 1Tab., Per Oral, Fasted
  • Drug AD-230 (Fed)
    AD-230 1 Tab., Per Oral, Fed state

Primary outcome measures

  • Area under the plasma concentration-time curve during dosing interval (AUCt) [Time frame: -24hours to 72hours]
  • Maximum concentration of drug in plasma (Cmax) [Time frame: -24hours to 72hours]

Eligibility criteria

Inclusion criteria

  • Body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at the time of screening visit
  • Subjects aged 19 years or older and under 65 years at the screening visit

Exclusion criteria

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

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
  • Kyungpook National university hospital — Daegu

Identifiers

NCT: NCT07618845 · AD-230FE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗