Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Daewoong Pharmaceutical Co. LTD.

Conditions:

Healthy Volunteers

Eligibility:

All Genders

19+ years

Phase:

PHASE1

Brief Summary

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

Detailed Description

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 DWC20231...

Eligibility Criteria

Inclusion

  • Over 19 year old
  • Healthy adult volunteers

Exclusion

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

Key Trial Info

Start Date :

October 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2025

Estimated Enrollment :

52 Patients enrolled

Trial Details

Trial ID

NCT06592495

Start Date

October 1 2024

End Date

October 1 2025

Last Update

September 23 2024

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