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Not yet recruitingNCT05954338Updated Jul 24, 2023

Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With DWC202307 in Healthy Adult Volunteers

A Phase 1 interventional study of DWC202307 and DWJ1543 in Healthy Volunteers, sponsored by Daewoong Pharmaceutical Co. LTD.. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-07-24.

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

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 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 the pharmacokinetics of DWJ1543 with concomitant multiple oral doses of DWC202307 in healthy adult volunteers.

Read the detailed description

The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.

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
No

Inclusion criteria

  • Over 19 year old
  • Healthy adult volunteer

Exclusion criteria

Exclusion Criteria:

  • Eye disorders including cataracts
  • Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders
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
    Intervention: DWC202307 + DWJ1543

    Drug: DWC202307 · Drug: DWJ1543

  • Experimental
    Intervention: DWC202307 + DWC202216

    Drug: DWC202307 · Drug: DWC202216

Interventions

  • DrugDWC202307

    DWC202307

  • DrugDWJ1543

    DWJ1543

  • DrugDWC202216

    DWC202216

06

What researchers measure

Primary outcomes

  1. Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543

    Time frame: At pre-dose (0 hour), and post-dose 1 to 120 hour.

  2. Area under the curve from the time of dosing to the last measurable concentration(AUClast) of DWJ1543

    Time frame: At pre-dose (0 hour), and post-dose 1 to 120 hour.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05954338
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Jul 20, 2023
Start date
Aug 1, 2023 (estimated)
Primary completion
Dec 1, 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Jul 24, 2023

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 Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Daewoong Pharmaceutical Co. LTD.

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