Drug-Drug Interaction Between DW4421 and Amoxicillin/Clarithromycin
ConditionHealthy Adult Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-50
SponsorDaewon Pharmaceutical Co., Ltd.
About this trial
Drug-Drug Interaction between DW4421 and Amoxicillin/Clarithromycin
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adult aged 19 to 50 (inclusive) years, at the time of screening.
Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
Disqualifiers
Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history.
Trial design
Design model
Crossover
Treatments tested in this trial
DW4421
Drug1 tablet will be orally administered
DW4421-1
Drug2 capsules will be orally administered
DW4421-2
Drug1 tablet will be orally administered
Treatment groups
36 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Sequence 1Experimental treatment 3 interventions
Group B: Sequence 2Experimental treatment 3 interventions
Group C: Sequence 3Experimental treatment 3 interventions
Group D: Sequence 4Experimental treatment 3 interventions
Group E: Sequence 5Experimental treatment 3 interventions
Group F: Sequence 6Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Cmax,ss: Maximum concentration of DW4421, DW4421-1 and DW4421-2 at steady state
Time frame
Up to day 6 or day 72
AUCτ,ss: Area under the drug concentration-time curve of DW4421, DW4421-1, DW4421-2 within a dosing interval at steady state
Time frame
Up to day 6 or day 7Sponsors 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: