Comparing the safety and pharmacokinetics of DWJ1567 in healthy adults
An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1567 and DWC202312 in Healthy Volunteers
This study is testing how safe and effective a new drug called DWJ1567 is compared to another drug in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Daewoong Pharmaceutical Co. LTD. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06109259 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetics and safety of DWJ1567 compared to DWC202312 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) of both drugs, while secondary endpoints assess additional pharmacokinetic parameters. The goal is to determine how DWJ1567 performs in comparison to the other drug.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 19 and older.
Not a fit: Patients with galactose intolerance or Lapp lactase deficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety and effectiveness of DWJ1567 for future therapeutic use.
How similar studies have performed: Other studies have successfully evaluated pharmacokinetics and safety in similar populations, indicating that this approach is well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over 19 year old Exclusion Criteria: * Galactose intolerance * Lapp lactase deficiency
Where this trial is running
Seoul
- H Plus YANGJI Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Seung-Hyun Kang, MD, Ph D
- Email: juspa@newyjh.com
- Phone: 070-4665-9490
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.