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Not yet recruiting NCT07590167

A Study to Evaluate the Safety and Pharmacokinetics of AD-231 Compared to Coadministration of AD-231A, AD-231D and AD-231C

Phase I Interventional Dyslipidemia Hypertension

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-231, AD-231A, AD-231D and AD-231C.
Who it may be relevant to
Registry conditions: Dyslipidemia, Hypertension. 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

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of AD-231 Compared to Coadministration of AD-231A, AD-231D and AD-231C in Healthy Adult Volunteers

Overview

A Study to Evaluate the Safety and Pharmacokinetics of AD-231 Compared to Coadministration of AD-231A, AD-231D and AD-231C

Interventions

  • Drug AD-231
    AD-231 Oral Tablet
  • Drug AD-231A, AD-231D and AD-231C
    AD-231A Oral Tablet + AD-231D Oral Tablet + AD-231C 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 and under 65 years 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: NCT07590167 · AD-231BE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗