Comparing the safety and pharmacokinetics of DWJ1568 in healthy adults
An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1568 and DWC202215 in Healthy Volunteers
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 |
| Enrollment | 44 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Daewoong Pharmaceutical Co. LTD. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06119945 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 19 years 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 DWJ1568, potentially leading to its approval for clinical use.
How similar studies have performed: Other studies have successfully utilized similar pharmacokinetic comparison approaches, indicating a precedent for this methodology.
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: MunJung Bae, MD, Ph D
- Email: m4222@newyjh.com
- Phone: 070-4665-9174
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.