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NCT Number: NCT06644404

Phase 1 Study of Drug-Drug Interactions 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

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Key information

Conditions

Healthy

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DWP16001 0.3mg

Drug

1 tablet, Orally, Once daily single dose

DWC202407 1,000mg

Drug

1 tablet, Orally, Twice daily

DWC202408 2mg

Drug

1 tablet, Orally, Once daily single dose

Primary outcomes

  1. Cmax,ss of DWP16001

    Time frame: 0-24 hours

    Peak Plasma Concentration at steady-state

  2. AUCtau,ss of DWP16001

    Time frame: 0-24 hours

    Area under the plasma concentration versus time curve at Tau, steady-state

  3. Cmax,ss of DWC202407

    Time frame: 0-12 hours

    Peak Plasma Concentration at steady-state

  4. AUCtau,ss of DWC202407

    Time frame: 0-12 hours

    Area under the plasma concentration versus time curve at Tau, steady-state

  5. Cmax,ss of DWC202408

    Time frame: 0-24 hours

    Peak Plasma Concentration at steady-state

  6. AUCtau,ss of DWC202408

    Time frame: 0-24 hours

    Area under the plasma concentration versus time curve at Tau, steady-state

Study contacts

Contact information is provided by the study sponsor or research team.

DaYe Jung

CONTACT

[email protected]

+82-2-550-8317

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Acronym: DW_DWP16001112

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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