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Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315

ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorDaewoong Pharmaceutical Co. LTD.

About this trial

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Over 19 year old

Healthy adult volunteers

Disqualifiers

with a history of mental disorder

For female volunteers, those who are suspected of being pregnant or lactating

Trial design

Design model

Crossover

Treatments tested in this trial

  • Period 1

    Drug

    DWJ1589 or DWC202315

  • Period 2

    Drug

    DWJ1589 or DWC202315

  • Period 3

    Drug

    DWJ1589 or DWC202315

  • Period 4

    Drug

    DWJ1589 or DWC202315

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Sequence A: RTRTExperimental treatment 4 interventions
Group B: Sequence B: TRTRExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

The maximum serum concentration(Cmax) of DWJ1589 and DWC202315

Cmax of DWJ1589 and DWC202315

Time frame
At pre-dose (0 hour), and post-dose 0.83 to 72 hour.
2

The Area under the curve(AUC)last of DWJ1589 and DWC202315

AUClast of DWJ1589 and DWC202315

Time frame
At pre-dose (0 hour), and post-dose 0.83 to 72 hour.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daewoong Pharmaceutical Co. LTD.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: