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Not yet recruiting NCT06592495

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

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Period 1, Period 2, Period 3, Period 4.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.

Interventions

  • Drug Period 1
    DWJ1589 or DWC202315
  • Drug Period 2
    DWJ1589 or DWC202315
  • Drug Period 3
    DWJ1589 or DWC202315
  • Drug Period 4
    DWJ1589 or DWC202315

Primary outcome measures

  • The maximum serum concentration(Cmax) of DWJ1589 and DWC202315 [Time frame: At pre-dose (0 hour), and post-dose 0.83 to 72 hour.]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06592495 · DW_DWJ1589101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗