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PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

ConditionHealthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-64
SponsorDaewoong Pharmaceutical Co. LTD.

About this trial

PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female participants aged ≥19 years and <65 years at the time of screening

Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight [kg] / height [m]²)

Disqualifiers

Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration.

Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration.

Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).

Trial design

Design model

Crossover

Treatments tested in this trial

  • DWJ1511

    Drug

    Test drug: DWJ1511

  • DWC202501

    Drug

    Comparator: DWC202501

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: A(RT)Experimental treatment 2 interventions
Group B: B(TR)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Area under the plasma drug concentration-time curve [AUCt]

Area under the plasma drug concentration-time curve \[AUCt\] of DWJ1511 and DWC202501

Time frame
0-12 Hours
2

Maximum plasma concentration [Cmax]

Maximum plasma concentration \[Cmax\] of DWJ1511 and DWC202501

Time frame
0-12 Hours

Secondary outcomes

1

Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]

Area under the plasma drug concentration-time curve from time 0 to infinity \[AUCinf\] of DWJ1511 and DWC202501

Time frame
0-12 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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