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Completed

NCT Number: NCT06858865

A Study to Evaluate the Safety and Pharmacokinetics of AD-228A Compared to Coadministration of AD-2281 and AD-2282

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228A in healthy subjects.

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Key information

Conditions

Primary Hypercholesterolaemia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H+ Yangji Hospital

Seoul, South Korea

About this study

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-228A compared with coadministration AD-2281 and AD-2282 in healthy subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AD-228A

Drug

AD-228A Oral Tablet

AD-2281 and AD-2282

Drug

AD-2281 Oral Tablet + AD-2282 Oral Tablet

Primary outcomes

  1. Maximum concentration of drug in plasma (Cmax)

    Time frame: pre-dose to 72 hours

    Cmax of AD-228A

  2. Area under the plasma concentration-time curve during dosing interval (AUCt)

    Time frame: pre-dose to 72 hours

    AUCt of AD-228A

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of AD-228A Compared to Coadministration of AD-2281 and AD-2282 in Healthy Adult Volunteers

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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