Bioequivalence Study betweenYHP2407 and YHR2502 in Healthy Subjects

An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2- Period, Crossover Study to Evaluate Bioequivalence Between YHP2407 and YHR2502 in Healthy Subjects

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2407 and YHR2502 in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: YHP2407; Drug: YHR2502

Detailed Description

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

Subjects in group 1 will be administered "comparator" and "YHP2407" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2407" and "comparator" by crossover design on period 1, 2.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Gimpo-si, Gyeonggi-do, Korea, Republic of, 10099
      • Gimpo Woori Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A(RT); 20 subjects, Cross-over, Single dose YHR2502 on period 1, Single dose of YHP2407 on period 2	Drug: YHP2407; Test drug: YHP2407, Comparator: YHR2502; Drug: YHR2502; Test drug: YHP2407, Comparator: YHR2502
Experimental: B(TR); 20 subjects, Cross-over, Single dose of YHP2407 on period 1, Single dose of YHR2502 on period 2	Drug: YHP2407; Test drug: YHP2407, Comparator: YHR2502; Drug: YHR2502; Test drug: YHP2407, Comparator: YHR2502

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma drug concentration-time curve [AUCt]	Area under the plasma drug concentration-time curve [AUCt] of Cefaclor Hydrate	0-6 hours
Maximum plasma concentration [Cmax]	Maximum plasma concentration [Cmax] of Cefaclor Hydrate	0-6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]	Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Cefaclor Hydrate	0-6 hours
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]	Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of Cefaclor Hydrate	0-6 hours
Time of peak concentration [Tmax]	Time of peak concentration [Tmax] of Cefaclor Hydrate	0-6 hours
Terminal phase of half-life [t1/2]	Terminal phase of half-life [t1/2] of Cefaclor Hydrate	0-6 hours

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Hyejin Lim, Gimpo Woori Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2025
• Primary Completion (Actual): April 19, 2025
• Study Completion (Actual): April 29, 2025

Study Registration Dates

• First Submitted: April 6, 2025
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Bioequivalence
• Other Study ID Numbers: YHP2407-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No