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Completed

NCT Number: NCT07256600

PK and Safety Comparison of DWJ445 and DWC202506 in Healthy Volunteers

A bioequivalence study comparing DWJ1445 and DWC202506 in healthy adults

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Key information

Conditions

Healthy Subjects

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H Plus Yangji Hospital

Seoul, South Korea

About this study

This is an open-label, randomized, single-dose, 2-treatment, 2-period, crossover, bioequivalence study conducted under fasting conditions to compare and evaluate the pharmacokinetics and safety of DWJ1445 and DWC202506 in healthy adult volunteers. Participants will receive both study drugs in separate periods, with a washout interval between administrations. The study aims to assess PK parameters and monitor safety through clinical evaluations and laboratory tests.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects with a body mass index (BMI) between 18 and 30 kg/m²
  • Subjects without any clinically significant congenital or chronic disease, and with no pathological findings based on medical examination
  • Subjects who agree to use a medically acceptable method of contraception

Exclusion criteria

  • Subjects who have participated in a bioequivalence or other clinical trial and received an investigational product within 6 months prior to the first dose
  • Subjects with a history of gastrointestinal surgery that may affect drug absorption
  • Subjects with a clinically significant history of psychiatric illness Female subjects who are pregnant, suspected of being pregnant, or currently breastfeeding

Treatment and study plan

DWJ1445

Drug

1 tablet, Orally

DWC202506

Drug

1 tablet, Orally

Primary outcomes

  1. Area under the plasma drug concentration-time curve [AUCt]

    Time frame: 0-24 hours

    Area under the plasma drug concentration-time curve [AUCt] of DWJ1445 and DWC202506

  2. Maximum plasma concentration [Cmax]

    Time frame: 0-24 hours

    Maximum plasma concentration [Cmax] of DWJ1445 and DWC202506

Secondary outcomes

  1. Area under the plasma drug concentration-time curve from time 0 to infinity

    Time frame: 0-24 hours

    Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of DWJ1445 and DWC202506

  2. Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]

    Time frame: 0-24 hours

    Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of DWJ1445 and DWC202506

  3. Time of peak concentration [Tmax]

    Time frame: 0-24 hours

    Time of peak concentration [Tmax] of Amoxicillin & Clavulanic acid of DWJ1445 and DWC202506

  4. Terminal phase of half-life [t1/2]

    Time frame: 0-24 hours

    Terminal phase of half-life of DWJ1445 and DWC202506

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence After Administration of "DWJ1445" and "DWC202506" in Healthy Adults

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 1, 2025
Registry last updated
Dec 3, 2025

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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