A Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-236A and AD-236B
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorAddpharma Inc.
About this trial
To evaluate the pharmacokinetic interaction and the safety of AD-236A and AD-236B in healthy adult volunteers
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adult volunteers aged ≥19 and ≤55 years at the time of the screening visit
Body weight ≥50 kg (≥45 kg for females) and body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of the 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
Parallel
Treatments tested in this trial
Treatment A(AD-236A)
DrugAD-236A Oral Tablet
Treatment B(AD-236B)
DrugAD-236B Oral Tablet
Treatment C(AD-236A+AD-236B)
DrugAD-236A+AD-236B Oral Tablet
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Arm AExperimental treatment 2 interventions
Group B: Arm BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
1. Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss)
AUCτ,ss
Time frame
pre-dose (0hour) to 24 hours post-dose2
Maximum concentration of drug in plasma at steady state (Cmax,ss)
Cmax,ss
Time frame
pre-dose (0hour) to 24 hours post-doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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