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Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1622, DWC202313, and DWC202314 in Healthy Volunteers Under Fasting Conditions

ConditionHealthy Volunteers
Trial statusRecruiting
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 of DWJ1622, DWC202313, and DWC202314 in healthy adult volunteers under fasting conditions.

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

  • DWJ1622

    Drug

    DWJ1622 (single oral dose) is administered in accordance with the study protocol.

  • DWC202313, DWC202314

    Drug

    DWC202313, DWC202314(single oral dose) is administered in accordance with the study protocol.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: DWJ1622Experimental treatment 2 interventions
Group B: DWC202313, DWC202314Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Cmax

Cmax of DWJ1622 and DWC202313, DWC202314

Time frame
At pre-dose (0 hours), and post-dose 1 to 72 hours.
2

AUClast

AUClast of DWJ1622 and DWC202313, DWC202314

Time frame
At pre-dose (0 hours), and post-dose 1 to 72 hours.

Secondary outcomes

1

AUCinf

AUCinf of DWJ1622 and DWC202313, DWC202314

Time frame
At pre-dose (0 hours), and post-dose 1 to 72 hours.
2

AUClast/AUCinf

AUClast/AUCinf of DWJ1622 and DWC202313, DWC202314

Time frame
At pre-dose (0 hours), and post-dose 1 to 72 hours.

Other outcomes

Sponsors and contacts

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

Daewoong Pharmaceutical Co. LTD.

Lead sponsor

Source ClinicalTrials.gov
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