Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 19 and up

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.

More Healthy Adult Male and Female Volunteers trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages19 Years and up
SexAll
Enrollment36 (estimated)
SponsorDaewoong Pharmaceutical Co. LTD.
Industry-sponsored
Locations1 site (Seoul, Gwanak-gu)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedJanuary 30, 2026
Study endsMay 30, 2026
Registry record updatedDecember 5, 2025
Trial IDNCT07267221 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.