Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects

July 20, 2025 updated by: Yuhan Corporation

An Open-label, Randomized, Fasting, Single-dose, Oral Administration, 2- Sequence, 2-period, Crossover Study to Evaluate Bioequivalence Study Between YHP2406 and YHR2501 in Healthy Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A(RT)
32 subjects, Cross-over, Single dose YHR2501 on period 1, Single dose of YHP2406 on period 2
Drug: YHP2406
Test drug: YHP2406, Comparator: YHR2501
Drug: YHR2501
Test drug: YHP2406, Comparator: YHR2501
Experimental: B(TR)
32 subjects, Cross-over, Single dose of YHP2406 on period 1, Single dose of YHR2501 on period 2
Drug: YHP2406
Test drug: YHP2406, Comparator: YHR2501
Drug: YHR2501
Test drug: YHP2406, Comparator: YHR2501

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma drug concentration-time curve [AUCt]
Time Frame: 0-8 hours
Area under the plasma drug concentration-time curve [AUCt] of Amoxicillin & Clavulanic acid
0-8 hours
Maximum plasma concentration [Cmax]
Time Frame: 0-8 hours
Maximum plasma concentration [Cmax] of Amoxicillin & Clavulanic acid
0-8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
Time Frame: 0-8 Hours
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Amoxicillin & Clavulanic acid
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]
Time Frame: 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
0-8 Hours
Time of peak concentration [Tmax]
Time Frame: 0-8 Hours
Time of peak concentration [Tmax] of Amoxicillin & Clavulanic acid of Amoxicillin & Clavulanic acid
0-8 Hours
Terminal phase of half-life [t1/2]
Time Frame: 0-8 Hours
Terminal phase of half-life [t1/2]
0-8 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuhan Corporation

Investigators

  • Principal Investigator: Seoung Hyun Kang, H Plus Yangji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2025

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

July 9, 2025

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 20, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • YHP2406-101

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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