Bioequivalence comparison between YHP2508B and YHR2602 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 volunteers. Four periods with two 2-sequence groups are used to compare YHP2508B to YHR2602, and YHP2508C to YHR2603, across two treatment blocks per group. A total of 44 healthy subjects will be randomized to either Group 1 or Group 2, with periods 1–4 following a replication crossover design. Primary focus is pharmacokinetic bioequivalence between the specified products.

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

• Gimpo Woori Hospital
  Gimpo-si, South Korea Recruiting

Study contacts

• Principal investigator: Hyeonsoo Park, MD — Gimpo Woori Hospital
• 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.