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Recruiting

NCT Number: NCT06884098

A Study to Compare PK Characteristics and Safety Profiles Between AD-228B and AD-2284

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

Recruiting

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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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body weight equal to or greater than 50kg (Female 45kg) and 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 other clinical study with an investigational drug within the 6 months from scheduled first administration
  • Other exclusions applied

Treatment and study plan

AD-228B

Drug

AD-228B, 1Tab., Per Oral

AD-2284

Drug

AD-2284, 1Tab., Per Oral

Primary outcomes

  1. Maximum concentration of drug in plasma (Cmax)

    Time frame: pre-dose (0hour) to 72hours

    Cmax of AD-228B

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

    Time frame: pre-dose (0hour) to 72hours

    AUCt of AD-228B

Study contacts

Contact information is provided by the study sponsor or research team.

JeongEun Park

CONTACT

[email protected]

+82-31-891-6989

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of AD-228B with AD-2284 in Healthy Adult Volunteers

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2025
Registry last updated
Mar 20, 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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