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NCT Number: NCT06592495

Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.

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Key information

Conditions

Healthy Volunteers

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Over 19 year old
  • Healthy adult volunteers

Exclusion criteria

  • with a history of mental disorder
  • For female volunteers, those who are suspected of being pregnant or lactating

Treatment and study plan

Period 1

Drug

DWJ1589 or DWC202315

Period 2

Drug

DWJ1589 or DWC202315

Period 3

Drug

DWJ1589 or DWC202315

Period 4

Drug

DWJ1589 or DWC202315

Primary outcomes

  1. The maximum serum concentration(Cmax) of DWJ1589 and DWC202315

    Time frame: At pre-dose (0 hour), and post-dose 0.83 to 72 hour.

    Cmax of DWJ1589 and DWC202315

  2. The Area under the curve(AUC)last of DWJ1589 and DWC202315

    Time frame: At pre-dose (0 hour), and post-dose 0.83 to 72 hour.

    AUClast of DWJ1589 and DWC202315

Study contacts

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

SHIN, CPL

CONTACT

02-550-8858

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315 in Healthy Adult Volunteers Under Fasting Conditions

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 23, 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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