A Phase 1 Clinical Trial to Evaluate the Safety and DDI of DW4421 and 3 NSAIDs
ConditionHealthy Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-50
SponsorDaewon Pharmaceutical Co., Ltd.
About this trial
Drug-Drug Interaction between DW4421 and three different kinds of NSAIDs
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
Parallel
Treatments tested in this trial
DW4421
DrugQD
DW4421-N1
DrugBID
DW4421-N2
DrugBID
DW4421-N3
DrugQD
Treatment groups
150 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cohort 1, AExperimental treatment 2 interventions
Group B: Cohort 1, BExperimental treatment 2 interventions
Group C: Cohort 2, CExperimental treatment 2 interventions
Group D: Cohort 2, DExperimental treatment 2 interventions
Group E: Cohort 3, EExperimental treatment 2 interventions
Group F: Cohort 3, FExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Cmax,ss
Time frame
Baseline to Day 13 or Day 152
AUCτ,ss
Time frame
Baseline to Day 13 or Day 15Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov