A Study to Compare to PK Characteristics and Safety Profiles Between AD-117 and AD-117A
ConditionMixed Dyslipidemia
Trial statusNot yet recruiting
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-117 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
AD-117
DrugAD-117 1Tab., Per Oral
AD-117A
DrugAD-117A 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-117
Time frame
pre-dose (0hour) to 72hours2
Area under the plasma concentration-time curve during dosing interval (AUCt)
AUCt of AD-117
Time frame
pre-dose (0hour) to 72hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: