Compare how DWJ1622 versus DWC202313 plus DWC202314 are absorbed and tolerated in fasting healthy adults
Official title: An Open-label, Randomized, Fasting, 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. · NCT07260851 · Data updated 2026-11-12
This test sees if a single oral dose of DWJ1622 is absorbed and tolerated similarly to taking DWC202313 and DWC202314 together in healthy adults after fasting.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Daewoong Pharmaceutical Co. LTD. Industry-sponsored |
| Locations | 1 site (Seoul, Gwanak-gu) |
| Status | Recruiting |
| Started | November 5, 2025 |
| Main results expected | January 30, 2026 |
| Study ends | May 30, 2026 |
| Registry record updated | December 17, 2025 |
| Trial ID | NCT07260851 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 19 years or older who can fast as required, have no significant medical or mental health history, and (for women) are not pregnant or lactating are eligible.
✕Probably not a fit
People looking for treatment of a medical condition should not expect therapeutic benefit because the study enrolls healthy volunteers, and pregnant or lactating women and those with a history of mental disorder are excluded.
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, 2-sequence, 2-period crossover Phase 1 study will give healthy adult volunteers either DWJ1622 or the combination of DWC202313 and DWC202314 across two periods with a washout between doses. Blood samples will be collected to measure pharmacokinetic parameters and compare Cmax and AUClast between treatments. Secondary PK measures include AUCinf, AUClast/AUCinf, Tmax, and terminal half-life (t1/2). Safety will be monitored through adverse event reporting and clinical laboratory tests.
Why it matters
Potential benefit: If successful, the results could support that the alternative dosing approach has similar pharmacokinetics and safety, informing future development or dosing options.
How similar studies have gone: Crossover bioequivalence studies in healthy volunteers are a common, well-established approach that has reliably characterized pharmacokinetics for comparable drugs.
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.