A Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-231A and AD-231B and AD-231C
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-64
SponsorAddpharma Inc.
About this trial
To evaluate the pharmacokinetic interactions of AD-231A, AD-231B, and AD-231C in healthy adult volunteers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adult volunteers aged ≥19 and <65 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-231A)
DrugAD-231A Oral Tablet
Treatment B(AD-231B+AD-231C)
DrugAD-231B+AD-231C Oral Tablet
Treatment C(AD-231A+AD-231B+AD-231C)
DrugAD-231A+AD-231B+AD-231C Oral Tablet
Treatment groups
55 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
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-dose on Day 142
Maximum concentration of drug in plasma at steady state (Cmax,ss)
Time frame
pre-dose (0hour) to 24 hours post-dose on Day 14Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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