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Not yet recruiting NCT07312773

A Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-231A and AD-231B and AD-231C

Phase I Interventional Hypertension Hyperlipidemia

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: Treatment A(AD-231A), Treatment B(AD-231B+AD-231C), Treatment C(AD-231A+AD-231B+AD-231C).
Who it may be relevant to
Registry conditions: Hypertension, Hyperlipidemia. 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 Two-arm, Open-label, Single-sequence, Multiple-dose Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-231A and AD-231B and AD-231C in Healthy Adult Volunteers

Overview

To evaluate the pharmacokinetic interactions of AD-231A, AD-231B, and AD-231C in healthy adult volunteers.

Interventions

  • Drug Treatment A(AD-231A)
    AD-231A Oral Tablet
  • Drug Treatment B(AD-231B+AD-231C)
    AD-231B+AD-231C Oral Tablet
  • Drug Treatment C(AD-231A+AD-231B+AD-231C)
    AD-231A+AD-231B+AD-231C Oral Tablet

Primary outcome measures

  • Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss) [Time frame: pre-dose (0hour) to 24 hours post-dose on Day 14]
  • Maximum concentration of drug in plasma at steady state (Cmax,ss) [Time frame: pre-dose (0hour) to 24 hours post-dose on Day 14]

Eligibility criteria

Inclusion criteria

  • Healthy adult volunteers aged ≥19 and <65 years at the time of the screening visit
  • Body weight ≥50 kg (≥45 kg for females) and body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of 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
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • H+ Yangji Hospital — Seoul

Identifiers

NCT: NCT07312773 · AD-231DDI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗