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Recruiting NCT06884098

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

Phase I Interventional Primary Hypercholesterolaemia

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-228B, AD-2284.
Who it may be relevant to
Registry conditions: Primary Hypercholesterolaemia. Basic parameters: from 19 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 Bioequivalence of AD-228B with AD-2284 in Healthy Adult Volunteers

Overview

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

Interventions

  • Drug AD-228B
    AD-228B, 1Tab., Per Oral
  • Drug AD-2284
    AD-2284, 1Tab., Per Oral

Primary outcome measures

  • Maximum concentration of drug in plasma (Cmax) [Time frame: pre-dose (0hour) to 72hours]
  • Area under the plasma concentration-time curve during dosing interval (AUCt) [Time frame: pre-dose (0hour) to 72hours]

Eligibility criteria

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

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 Hospital — Seoul

Identifiers

NCT: NCT06884098 · AD-228BE-H

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗