Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects

Phase 1

Not yet recruiting

• Conditions: Healthy Subject
• Interventions: Drug: YHP2406; Drug: YHR2501

• Registration Number: NCT06920719
• Lead Sponsor: Yuhan Corporation

Brief Summary

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2406 and YHR2501 in healthy volunteers

Detailed Description

62 healthy subjects will be randomized to one of the 2 groups in the same ratio.

Subjects in group 1 will be administered "comparator" and "YHP2406" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2406" and "comparator" by crossover design on period 1, 2.

Study Timeline

• Study First Submitted: 2025-03-27
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10
• Study Start: 2025-04-20
• Primary Completion: 2025-04-23
• Study Completion: 2025-04-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A(RT)	YHP2406	32 subjects, Cross-over, Single dose YHR2501 on period 1, Single dose of YHP2406 on period 2
A(RT)	YHR2501	32 subjects, Cross-over, Single dose YHR2501 on period 1, Single dose of YHP2406 on period 2
B(TR)	YHP2406	32 subjects, Cross-over, Single dose of YHP2406 on period 1, Single dose of YHR2501 on period 2
B(TR)	YHR2501	32 subjects, Cross-over, Single dose of YHP2406 on period 1, Single dose of YHR2501 on period 2

Primary Outcome Measures

Name	Time	Method
Area under the plasma drug concentration-time curve [AUCt]	0-8 hours	Area under the plasma drug concentration-time curve \[AUCt\] of Amoxicillin \& Clavulanic acid
Maximum plasma concentration [Cmax]	0-8 hours	Maximum plasma concentration \[Cmax\] of Amoxicillin \& Clavulanic acid

Secondary Outcome Measures

Name	Time	Method
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]	0-8 Hours	Area under the plasma drug concentration-time curve from time 0 to infinity \[AUCinf\] of Amoxicillin \& Clavulanic acid
Time of peak concentration [Tmax]	0-8 Hours	Time of peak concentration \[Tmax\] of Amoxicillin \& Clavulanic acid of Amoxicillin \& Clavulanic acid
Terminal phase of half-life [t1/2]	0-8 Hours	Terminal phase of half-life \[t1/2\]
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]	0-8 Hours	Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity \[AUCt/AUCinf\] of Amoxicillin \& Clavulanic acid

Trial Locations

Locations (1)

H Plus Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of