RecruitingPhase 1NCT07470125

Bioequivalence (BE) Study Between YHP2511 and YHP2511A in Healthy Volunteers

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of YHP2511 With YHP2511A in Healthy Adult Volunteers

Sponsor

Yuhan Corporation

Enrollment

60 participants

Start Date

Jun 23, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Subjects

Summary

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2511 and YHP2511A in healthy volunteers

Eligibility

Min Age: 19 YearsMax Age: 55 Years

Inclusion Criteria4

Adults aged 19 to 55 years at the time of screening visit.
Those whose weight is ≥ 50 kg (≥ 45 kg for females) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination
Those who express their voluntary consent to participate in the trial by signing a written consent

Exclusion Criteria3

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

Interested in this trial?

Get notified about updates and connect with the research team.