Phase 1 Study of Drug-Drug Interactions Between DWP16001, DWC202407, and DWC202408 in Healthy Adults
DW_DWP16001112
A Randomized, Open, Two-sequence, Crossover, Multiple Oral Administrations, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Drug-drug Interaction Between DWP16001, DWC202407, and DWC202408 in Healthy Adults
1 other identifier
interventional
34
1 country
1
Brief Summary
This study aims to evaluate the pharmacokinetic/pharmacodynamic drug-drug interactions between DWP16001, DWC202407, and DWC202408 in healthy adults
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Oct 2024
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2024
CompletedFirst Posted
Study publicly available on registry
October 16, 2024
CompletedStudy Start
First participant enrolled
October 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedOctober 16, 2024
October 1, 2024
1 month
October 11, 2024
October 14, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
Cmax,ss of DWP16001
Peak Plasma Concentration at steady-state
0-24 hours
AUCtau,ss of DWP16001
Area under the plasma concentration versus time curve at Tau, steady-state
0-24 hours
Cmax,ss of DWC202407
Peak Plasma Concentration at steady-state
0-12 hours
AUCtau,ss of DWC202407
Area under the plasma concentration versus time curve at Tau, steady-state
0-12 hours
Cmax,ss of DWC202408
Peak Plasma Concentration at steady-state
0-24 hours
AUCtau,ss of DWC202408
Area under the plasma concentration versus time curve at Tau, steady-state
0-24 hours
Study Arms (3)
Enavogliflozin 0.3mg, once daily
EXPERIMENTALMetformin 1,000mg, BID
EXPERIMENTALGlimepiride 2mg, once daily
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2024
First Posted
October 16, 2024
Study Start
October 26, 2024
Primary Completion
December 3, 2024
Study Completion
April 1, 2025
Last Updated
October 16, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share