Bioequivalence Study Between YHP2305 and YHR2404 in Healthy Volunteers

Launched by YUHAN CORPORATION · Sep 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two medications called YHP2305 and YHR2404 to see if they work the same way in healthy individuals. The trial is open to healthy volunteers aged 19 and older who meet specific weight and body mass index (BMI) criteria. Participants will take either of the medications in a single dose and will be involved in two different periods during the study.

To be eligible, volunteers must weigh at least 50 kg (about 110 lbs) for males or 45 kg (about 99 lbs) for females, and their BMI should fall between 18.0 and 30.0. It's important that participants haven't taken part in any other clinical trials in the last six months. Those who choose to participate will sign a consent form and will be closely monitored throughout the study. This research aims to ensure that both medications are similar in how they affect the body, which is important for safety and effectiveness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Those who are 19 years old or older at the screening visit
• • Those whose weight is over 50kg(male), over 45kg(female) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
• • Those who express their voluntary consent to participate in the trial by signing a written consent
• • Those who are judged eligible to participate in the trial by the principal investigator(or delegated investigators) after screening test
• Exclusion Criteria:
• • 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.