Comparing the safety and pharmacokinetics of DWJ1568 in healthy adults
Official title: An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1568 and DWC202215 in Healthy Volunteers
Run by Daewoong Pharmaceutical Co. LTD. · NCT06119945 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing the safety and how the body processes a new drug called DWJ1568 compared to another drug in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | Daewoong Pharmaceutical Co. LTD. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06119945 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are healthy adults aged 19 years and older.
✕Probably not a fit
Patients with galactose intolerance or Lapp lactase deficiency may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the pharmacokinetics and safety of DWJ1568 compared to DWC202215 in healthy adult volunteers. It employs a randomized, open-label, oral, single-dose, four-way crossover design, where participants are assigned to receive each treatment in a sequence. The primary endpoints include the maximum concentration (Cmax) and area under the curve (AUCt) for both drugs, while secondary endpoints assess additional pharmacokinetic parameters. The goal is to determine how DWJ1568 performs in comparison to the reference drug.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety and effectiveness of DWJ1568, potentially leading to its approval for clinical use.
How similar studies have gone: Other studies have successfully utilized similar pharmacokinetic comparison approaches, indicating a precedent for this methodology.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * over 19 year old Exclusion Criteria: * Galactose intolerance * Lapp lactase deficiency
Where it's running
-
H Plus YANGJI Hospital
Seoul, Korea, Republic of Recruiting
Study contacts
- Study coordinator: MunJung Bae, MD, Ph D
- Email: m4222@newyjh.com
- Phone: 070-4665-9174
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.