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Completed

NCT Number: NCT06920719

Bioequivalence Study betweenYHP2406 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

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Key information

Conditions

Healthy Subject

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H Plus Yangji Hospital

Seoul, 08779, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

YHP2406

Drug

Test drug: YHP2406, Comparator: YHR2501

YHR2501

Drug

Test drug: YHP2406, Comparator: YHR2501

Primary outcomes

  1. 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

  2. Maximum plasma concentration [Cmax]

    Time frame: 0-8 hours

    Maximum plasma concentration [Cmax] of Amoxicillin & Clavulanic acid

Secondary outcomes

  1. 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

  2. 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

  3. Time of peak concentration [Tmax]

    Time frame: 0-8 Hours

    Time of peak concentration [Tmax] of Amoxicillin & Clavulanic acid of Amoxicillin & Clavulanic acid

  4. Terminal phase of half-life [t1/2]

    Time frame: 0-8 Hours

    Terminal phase of half-life [t1/2]

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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