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Phase 1 Study of Drug-Drug Interactions Between DWP16001, DWC202407, and DWC202408 in Healthy Adults

ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-50
SponsorDaewoong Pharmaceutical Co. LTD.

About this trial

This study aims to evaluate the pharmacokinetic/pharmacodynamic drug-drug interactions between DWP16001, DWC202407, and DWC202408 in healthy adults

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adult volunteers aged 19 to 50 years at the time of screening.

Individuals with a body weight between 50.0 kg and 90.0 kg and a Body Mass Index (BMI) between 18.5 kg/m² and 29.9 kg/m² at the time of screening.

Female volunteers must be neither pregnant nor breastfeeding, or must be in a surgically sterile state (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy).

Individuals who have been fully informed about the clinical trial, have fully understood the details, voluntarily decided to participate, and provided written consent to comply with the precautions.

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • DWP16001 0.3mg

    Drug

    1 tablet, Orally, Once daily single dose

  • DWC202407 1,000mg

    Drug

    1 tablet, Orally, Twice daily

  • DWC202408 2mg

    Drug

    1 tablet, Orally, Once daily single dose

Treatment groups

34 Participants
are divided into 3 treatment groups
Group A: Enavogliflozin 0.3mg, once dailyExperimental treatment 1 intervention
Group B: Metformin 1,000mg, BIDExperimental treatment 1 intervention
Group C: Glimepiride 2mg, once dailyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cmax,ss of DWP16001

Peak Plasma Concentration at steady-state

Time frame
0-24 hours
2

AUCtau,ss of DWP16001

Area under the plasma concentration versus time curve at Tau, steady-state

Time frame
0-24 hours
3

Cmax,ss of DWC202407

Peak Plasma Concentration at steady-state

Time frame
0-12 hours
4

AUCtau,ss of DWC202407

Area under the plasma concentration versus time curve at Tau, steady-state

Time frame
0-12 hours

Secondary outcomes

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

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