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

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: DWP16001 0.3mg; Drug: DWC202407 1,000mg; Drug: DWC202408 2mg

• Registration Number: NCT06644404
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Study Start: 2024-10-26
• Primary Completion: 2024-12-03
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Enavogliflozin 0.3mg, once daily	DWP16001 0.3mg	-
Metformin 1,000mg, BID	DWC202407 1,000mg	-
Glimepiride 2mg, once daily	DWC202408 2mg	-

Primary Outcome Measures

Name	Time	Method
Cmax,ss of DWC202407	0-12 hours	Peak Plasma Concentration at steady-state
AUCtau,ss of DWC202407	0-12 hours	Area under the plasma concentration versus time curve at Tau, steady-state
Cmax,ss of DWC202408	0-24 hours	Peak Plasma Concentration at steady-state
AUCtau,ss of DWC202408	0-24 hours	Area under the plasma concentration versus time curve at Tau, steady-state
Cmax,ss of DWP16001	0-24 hours	Peak Plasma Concentration at steady-state
AUCtau,ss of DWP16001	0-24 hours	Area under the plasma concentration versus time curve at Tau, steady-state

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of