A Study to Evaluate the Bioequivalence of DA-5230 Compared to DA-5230-R
ConditionHealthy Adult Participants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorDong-A ST Co., Ltd.
About this trial
A study to evaluate the bioequivalence of DA-5230 compared to DA-5230-R
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy participants aged 19 to 55 years at the time of screening visit
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
Disqualifiers
Participants who have received an investigational product in another clinical trial or a bioequivalence study within 6 months prior to the first dosing
Participants deemed unsuitable for participation in this clinical trial by the investigator
Trial design
Design model
Crossover
Treatments tested in this trial
DA-5230
DrugTest drug
DA-5230-R
DrugReference drug
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Sequence AExperimental treatment 2 interventions
Group B: Sequence BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
AUCt
Area under the plasma concentration-time curve during dosing interval (AUCt)
Time frame
pre-dose (0hour) to 72hours2
Cmax
Maximum concentration of drug in plasma
Time frame
pre-dose (0hour) to 72hoursLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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