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

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06644404

Acronym

DW_DWP16001112

Enrollment

Registered

2024-10-16

Start date

2024-10-26

Completion date

2025-04-01

Last updated

2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGDWP16001 0.3mg

1 tablet, Orally, Once daily single dose

DRUGDWC202407 1,000mg

1 tablet, Orally, Twice daily

DRUGDWC202408 2mg

1 tablet, Orally, Once daily single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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
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

Countries

South Korea

Contacts

Primary ContactDaYe Jung

dayejung@daewoong.co.kr+82-2-550-8317

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026