Bioequivalence of DWJ1622 versus DWC202313 plus DWC202314 in fed healthy adults
An Open-label, Randomized, Fed, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "DWJ1622" and Co-administration of "DWC202313" and "DWC202314" in Healthy Volunteers
This study will test whether a single oral dose of DWJ1622 gives similar safety and blood levels as taking DWC202313 with DWC202314 in healthy adults after a meal.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Daewoong Pharmaceutical Co. LTD. Industry-sponsored |
| Locations | 1 site (Seoul, Gwanak-gu) |
| Trial ID | NCT07267221 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized, single-dose, two-sequence, two-period crossover Phase 1 trial compares oral DWJ1622 to the co-administration of DWC202313 and DWC202314 in healthy adults under fed conditions. Participants are randomized to receive each treatment in different periods with an appropriate washout while blood samples are collected for pharmacokinetic analysis. Primary endpoints are Cmax and AUClast for each drug, with secondary PK measures including AUCinf, AUClast/AUCinf, Tmax, and t1/2; safety is monitored via adverse events and clinical laboratory tests. The study is conducted at a single site in Seoul and enrolls healthy volunteers aged 19 and older.
Who should consider this trial
Good fit: Healthy adults aged 19 or older who are not pregnant or lactating and who have no history of mental disorder are ideal candidates for participation.
Not a fit: People with active medical conditions, pregnant or breastfeeding women, individuals with a history of mental disorder, or patients seeking therapeutic benefit are unlikely to receive clinical benefit from this healthy-volunteer PK study.
Why it matters
Potential benefit: If the formulations show comparable pharmacokinetics and acceptable safety, the results could support using the products interchangeably and speed their further development.
How similar studies have performed: Crossover bioequivalence and PK studies in healthy volunteers are a well-established and commonly successful approach for oral drugs, though these specific compounds appear to be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over 19 year old * Healthy adult volunteers Exclusion Criteria: * with a history of mental disorder * For female volunteers, those who are suspected of being pregnant or lactating
Where this trial is running
Seoul, Gwanak-gu
- H Plus YANGJI Hospital — Seoul, Gwanak-gu, South Korea (Recruiting)
Study contacts
- Study coordinator: Shin
- Email: hbshin028@daewoong.co.kr
- Phone: 825508858
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.