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

October 14, 2024 updated by: Daewoong Pharmaceutical Co. LTD.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enavogliflozin 0.3mg, once daily
Drug: DWP16001 0.3mg
1 tablet, Orally, Once daily single dose
Experimental: Metformin 1,000mg, BID
Drug: DWC202407 1,000mg
1 tablet, Orally, Twice daily
Experimental: Glimepiride 2mg, once daily
Drug: DWC202408 2mg
1 tablet, Orally, Once daily single dose

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 26, 2024

Primary Completion (Estimated)

December 3, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 14, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • DW_DWP16001112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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