RecruitingPhase 1NCT06884098

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

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

Sponsor

Addpharma Inc.

Enrollment

60 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

Primary Hypercholesterolaemia

Summary

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

Eligibility

Min Age: 19 Years

Inclusion Criteria2

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 Criteria2

Participation in other clinical study with an investigational drug within the 6 months from scheduled first administration
Other exclusions applied

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Interventions

DRUGAD-228B

AD-228B, 1Tab., Per Oral

DRUGAD-2284

AD-2284, 1Tab., Per Oral

Locations(1)

H Plus Yangji Hospital

Seoul, South Korea

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NCT06884098