Compare how DWJ1622 versus DWC202313 plus DWC202314 are absorbed and tolerated in fasting healthy adults
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
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 |
| Enrollment | 40 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Daewoong Pharmaceutical Co. LTD. Industry-sponsored |
| Locations | 1 site (Seoul, Gwanak-gu) |
| Trial ID | NCT07260851 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Crossover bioequivalence studies in healthy volunteers are a common, well-established approach that has reliably characterized pharmacokinetics for comparable drugs.
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.