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Not yet recruiting NCT07538466

A Study to Evaluate the Safety and Pharmacokinetics of AD-123 Compared to Coadministration of AD-1231 and AD-1232

Phase I Interventional Diabetes Mellitus

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-123, AD-1231 and AD-1232.
Who it may be relevant to
Registry conditions: Diabetes Mellitus. Basic parameters: from 19 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

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of AD-123 Compared to Coadministration of AD-1231 and AD-1232 in Healthy Adult Volunteers Under Fasting Conditions

Overview

A Study to Evaluate the Safety and Pharmacokinetics of AD-123 Compared to Coadministration of AD-1231 and AD-1232

Interventions

  • Drug AD-123
    AD-123 Oral Tablet
  • Drug AD-1231 and AD-1232
    AD-1231 Oral Tablet + AD-1232 Oral Tablet

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • Body mass index (BMI) between 18.0 kg/m2 and 30.0 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

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
  • H Plus Yangji Hospita — Seoul

Identifiers

NCT: NCT07538466 · AD-123BE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗