Bioequivalence of DWJ1622 versus DWC202313 plus DWC202314 in fed healthy adults
Official title: 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
Run by Daewoong Pharmaceutical Co. LTD. · NCT07267221 · Data updated 2026-11-12
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 |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Daewoong Pharmaceutical Co. LTD. Industry-sponsored |
| Locations | 1 site (Seoul, Gwanak-gu) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | January 30, 2026 |
| Study ends | May 30, 2026 |
| Registry record updated | December 5, 2025 |
| Trial ID | NCT07267221 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
H Plus YANGJI Hospital
Seoul, Gwanak-gu, South Korea Recruiting
Study contacts
- Study coordinator: Shin
- Email: hbshin028@daewoong.co.kr
- Phone: 825508858
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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.