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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06884098

Enrollment

Registered

2025-03-19

Start date

2025-03-10

Completion date

2025-04-30

Last updated

2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypercholesterolaemia

Brief summary

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

Interventions

DRUGAD-228B

AD-228B, 1Tab., Per Oral

DRUGAD-2284

AD-2284, 1Tab., Per Oral

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Maximum concentration of drug in plasma (Cmax)	pre-dose (0hour) to 72hours	Cmax of AD-228B
Area under the plasma concentration-time curve during dosing interval (AUCt)	pre-dose (0hour) to 72hours	AUCt of AD-228B

Countries

South Korea

Contacts

Primary ContactJeongEun Park

parkje@addpharma.co.kr+82-31-891-6989

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026