CClinicalTrials.gg
Not yet recruitingNCT06592495Updated Sep 23, 2024

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

A Phase 1 interventional study of Period 1 and Period 2 in Healthy Volunteers, sponsored by Daewoong Pharmaceutical Co. LTD.. Not yet recruiting. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-23.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Over 19 year old
  • Healthy adult volunteers

Exclusion criteria

Exclusion Criteria:

  • with a history of mental disorder
  • For female volunteers, those who are suspected of being pregnant or lactating
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    Sequence A: RTRT

    T: DWJ1589 R: DWC202315

    Drug: Period 1 · Drug: Period 2 · Drug: Period 3 · Drug: Period 4

  • Experimental
    Sequence B: TRTR

    T: DWJ1589 R: DWC202315

    Drug: Period 1 · Drug: Period 2 · Drug: Period 3 · Drug: Period 4

Interventions

  • DrugPeriod 1

    DWJ1589 or DWC202315

  • DrugPeriod 2

    DWJ1589 or DWC202315

  • DrugPeriod 3

    DWJ1589 or DWC202315

  • DrugPeriod 4

    DWJ1589 or DWC202315

06

What researchers measure

Primary outcomes

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

    Cmax of DWJ1589 and DWC202315

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

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

    AUClast of DWJ1589 and DWC202315

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06592495
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Oct 2024 (estimated)
Primary completion
Jan 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Sep 23, 2024

Study contacts

SHIN, CPL
Contact
02-550-8858
KANG, MD, PhD
principal investigator · H Plus Yangji Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion