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Clinical Trials/NCT06592495
NCT06592495Not yet recruitingPhase 1

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

Daewoong Pharmaceutical Co. LTD.0 sites52 target enrollmentStarted: October 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Sponsor
Enrollment
52
Primary Endpoint
The maximum serum concentration(Cmax) of DWJ1589 and DWC202315

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Sequence A: RTRT

Experimental

T: DWJ1589 R: DWC202315

Intervention: Period 4 (Drug)

Sequence B: TRTR

Experimental

T: DWJ1589 R: DWC202315

Intervention: Period 1 (Drug)

Sequence B: TRTR

Experimental

T: DWJ1589 R: DWC202315

Intervention: Period 2 (Drug)

Sequence B: TRTR

Experimental

T: DWJ1589 R: DWC202315

Intervention: Period 3 (Drug)

Sequence B: TRTR

Experimental

T: DWJ1589 R: DWC202315

Intervention: Period 4 (Drug)

Sequence A: RTRT

Experimental

T: DWJ1589 R: DWC202315

Intervention: Period 2 (Drug)

Sequence A: RTRT

Experimental

T: DWJ1589 R: DWC202315

Intervention: Period 3 (Drug)

Sequence A: RTRT

Experimental

T: DWJ1589 R: DWC202315

Intervention: Period 1 (Drug)

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Daewoong Pharmaceutical Co. LTD.
Sponsor Class
Industry
Responsible Party
Sponsor

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