A Study to Compare PK Characteristics and Safety Profiles Between AD-228B and AD-2284
ConditionPrimary Hypercholesterolaemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorAddpharma Inc.
About this trial
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228B in healthy subjects.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Participation in other clinical study with an investigational drug within the 6 months from scheduled first administration
Other exclusions applied
Trial design
Design model
Crossover
Treatments tested in this trial
AD-228B
DrugAD-228B, 1Tab., Per Oral
AD-2284
DrugAD-2284, 1Tab., Per Oral
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Sequence A (RT)Experimental treatment 2 interventions
Group B: Sequence B (TR)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Maximum concentration of drug in plasma (Cmax)
Cmax of AD-228B
Time frame
pre-dose (0hour) to 72hours2
Area under the plasma concentration-time curve during dosing interval (AUCt)
AUCt of AD-228B
Time frame
pre-dose (0hour) to 72hoursSponsors and contacts
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Source ClinicalTrials.gov