A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A
ConditionMixed Dyslipidemia
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 PA-111 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 another 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
PA-111
DrugPA-111 1Tab., Per Oral
PA-111A
DrugPA-111A 1Capsule., Per Oral
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Sequence A (RT)Experimental treatment 2 interventions
Group B: Sequence A (TR)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Maximum concentration of drug in plasma (Cmax)
Cmax of PA-111
Time frame
pre-dose (0hour) to 72hours2
Area under the plasma concentration-time curve during dosing interval (AUCt)
AUCt of PA-111
Time frame
pre-dose (0hour) to 72hoursSponsors and contacts
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Source ClinicalTrials.gov