Single-dose crossover comparison of DWJ1511 and DWC202501 in healthy adults
An Open-label, Randomized, Fasting, Single-dose, Two-treatment, Two-period, Crossover, Phase 1 Clinical Trial to Compare and Evaluate the Pharmacokinetics and Safety of "DWJ1511" and "DWC202501" in Healthy Adult Volunteers
This will test how two single doses of DWJ1511 and DWC202501 are absorbed and cleared, and whether they are safe in healthy adults aged 19–64.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 19 Years to 64 Years |
| Sex | All |
| Sponsor | Daewoong Pharmaceutical Co. LTD. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07144176 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized, single-dose, two-treatment, two-period crossover phase 1 trial compares the pharmacokinetics and safety of DWJ1511 and DWC202501 under fasting conditions in healthy adult volunteers. Each participant receives both investigational products in separate periods with a washout interval between administrations. The study measures standard PK parameters (such as Cmax and AUC) and monitors safety via clinical evaluations and laboratory tests. Results will inform selection and dosing for future clinical development.
Who should consider this trial
Good fit: Healthy adults aged 19–64 years with BMI 18–30 kg/m² who meet trial screening criteria and have not recently received investigational products or disallowed blood donations are the intended participants.
Not a fit: People with active medical conditions, those outside the age or BMI limits, pregnant or breastfeeding individuals, or anyone who recently received investigational drugs or significant blood donations are unlikely to receive benefit from participating.
Why it matters
Potential benefit: If successful, this could show whether DWJ1511 has a matching PK and safety profile to DWC202501 and help decide which formulation proceeds to patient studies.
How similar studies have performed: Single-dose randomized crossover PK/safety studies in healthy volunteers are a standard design and have routinely succeeded in characterizing pharmacokinetics for similar compounds.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female participants aged ≥19 years and \<65 years at the time of screening * Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight \[kg\] / height \[m\]²) Exclusion Criteria: * Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration. * Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration. * Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).
Where this trial is running
Seoul
- H Plus Yangji Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Kang
- Email: juspa@newyjh.com
- Phone: 82) 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.