Bioequivalence Study Between YHP2305 and YHR2404 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: YHP2305; Drug: YHR2404

• Registration Number: NCT06613139
• Lead Sponsor: Yuhan Corporation

Brief Summary

An open-label, randomized, single-dose, oral administration, 2-sequence, 2- period, crossover study to evaluate bioequivalence between YHP2305 and YHR2404 in healthy subjects

Detailed Description

Subjects in group A will be administered comparator and YHP2305 by crossover design on day 1, 8.

Subjects in group B will be administered YHP2305 and comparator by crossover design on day 1, 8.

Study Timeline

• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-25
• Study Start: 2024-10-06
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A(RT)	YHP2305	17 subjects, Cross-over, Single dose of YHR2404 on day 1, Single dose of YHP2305 on day 8
Group A(RT)	YHR2404	17 subjects, Cross-over, Single dose of YHR2404 on day 1, Single dose of YHP2305 on day 8
Group B(TR)	YHP2305	17 subjects, Cross-over, Single dose of YHP2305 on day 1, Single dose of YHR2404 on day 8
Group B(TR)	YHR2404	17 subjects, Cross-over, Single dose of YHP2305 on day 1, Single dose of YHR2404 on day 8

Primary Outcome Measures

Name	Time	Method
Area under the plasma drug concentration-time curve [AUCt]	0-36 hours
Maximum plasma concentration [Cmax]	0-36 hours

Secondary Outcome Measures

Name	Time	Method
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]	0-36 hours
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]	0-36 hours
Time of peak concentration [Tmax]	0-36 hours
Terminal phase of half-life [t1/2]	0-36 hours

Trial Locations

Locations (1)

Bumin Hospital; 🇰🇷 Seoul, Korea, Republic of