Phase 1 Study of Drug-Drug Interactions Between DWP16001, DWC202407, and DWC202408 in Healthy Adults (DW_DWP16001112)

Daewoong Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: DWP16001 0.3mg; Drug: DWC202407 1,000mg; Drug: DWC202408 2mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06644404

DW_DWP16001112

Details and patient eligibility

About

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

Full description

This study aims to evaluate the pharmacokinetic interactions, pharmacodynamic interactions, safety, and tolerability of DWP16001, DWC202407, and DWC202408 in healthy adults

Enrollment: 34 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Healthy adult volunteers aged 19 to 50 years at the time of screening.
2. 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.
3. 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).
4. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 3 patient groups

Enavogliflozin 0.3mg, once daily

Experimental group

Treatment:

Drug: DWP16001 0.3mg

Metformin 1,000mg, BID

Experimental group

Treatment:

Drug: DWC202407 1,000mg

Glimepiride 2mg, once daily

Experimental group

Treatment:

Drug: DWC202408 2mg