Single-dose crossover comparison of DWJ1511 and DWC202501 in healthy adults

Is this trial a fit for you?

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-treatment, two-period crossover phase 1 trial compares the pharmacokinetics and safety of DWJ1511 and DWC202501 under fasting conditions in healthy adult volunteers. Each participant receives both investigational products in separate periods with a washout interval between administrations. The study measures standard PK parameters (such as Cmax and AUC) and monitors safety via clinical evaluations and laboratory tests. Results will inform selection and dosing for future clinical development.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female participants aged ≥19 years and \<65 years at the time of screening
* Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight \[kg\] / height \[m\]²)

Exclusion Criteria:

* Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration.
* Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration.
* Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).

Where it's running

• H Plus Yangji Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Kang
• Email: juspa@newyjh.com
• Phone: 82) 070-4665-9490

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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.