Bioequivalence test of two drugs 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 is a Phase 1, open-label, randomized, fasting, single-dose, oral crossover study in healthy adults. Participants are assigned to two groups and receive both drugs in different sequences across four periods to compare how the body processes each drug. The trial uses two 2-sequence, 4-period replicate crossover designs to determine bioequivalence. About 44 healthy subjects will be enrolled to ensure reliable comparison. The study aims to determine if the two formulations behave similarly in pharmacokinetics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* BMI 18-30 kg/m2
* Those without clinically significant congenital or chronic diseases

Exclusion Criteria:

* Those who have participated in a bioequivalence study or other clinical trials and have been administered investigational products within 6 months prior to the first administration
* Those who are judged ineligible to participate in the trial by the principal investigator
* Female volunteers who are pregnant, suspected to be pregnant or breathfeeding

Where it's running

• H+ Yangji Hospital
  Seoul, South Korea Recruiting
• H+ Yangji Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Jungwook Lee, MS
• Email: clinicaltrials@yuhan.co.kr
• Phone: 82-2-828-0504

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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.