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Not yet recruiting NCT06644404

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

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DWP16001 0.3mg, DWC202407 1,000mg, DWC202408 2mg.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 19 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug DWP16001 0.3mg
    1 tablet, Orally, Once daily single dose
  • Drug DWC202407 1,000mg
    1 tablet, Orally, Twice daily
  • Drug DWC202408 2mg
    1 tablet, Orally, Once daily single dose

Primary outcome measures

  • Cmax,ss of DWP16001 [Time frame: 0-24 hours]
  • AUCtau,ss of DWP16001 [Time frame: 0-24 hours]
  • Cmax,ss of DWC202407 [Time frame: 0-12 hours]
  • AUCtau,ss of DWC202407 [Time frame: 0-12 hours]
  • Cmax,ss of DWC202408 [Time frame: 0-24 hours]
  • AUCtau,ss of DWC202408 [Time frame: 0-24 hours]

Eligibility criteria

Inclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT06644404 · DW_DWP16001112

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗