Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects

NCT06920719 | Completed Phase 1

• 1 other identifier: YHP2406-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Subject

Keywords

Pharmacokinetics; Bioequivalence

Outcome Measures

Primary Outcomes (2)

• Area under the plasma drug concentration-time curve [AUCt]

  Area under the plasma drug concentration-time curve \[AUCt\] of Amoxicillin \& Clavulanic acid

  0-8 hours

• Maximum plasma concentration [Cmax]

  Maximum plasma concentration \[Cmax\] of Amoxicillin \& Clavulanic acid

  0-8 hours

Secondary Outcomes (4)

• 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/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]

  0-8 Hours

• Time of peak concentration [Tmax]

  0-8 Hours

• Terminal phase of half-life [t1/2]

  0-8 Hours

Study Arms (2)

A(RT)

EXPERIMENTAL

32 subjects, Cross-over, Single dose YHR2501 on period 1, Single dose of YHP2406 on period 2

Drug: YHP2406; Drug: YHR2501

B(TR)

EXPERIMENTAL

32 subjects, Cross-over, Single dose of YHP2406 on period 1, Single dose of YHR2501 on period 2

Drug: YHP2406; Drug: YHR2501

Interventions

YHP2406 DRUG

Test drug: YHP2406, Comparator: YHR2501

A(RT); B(TR)

YHR2501 DRUG

Test drug: YHP2406, Comparator: YHR2501

A(RT); B(TR)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 18-30 kg/m2
• Those without clinically significant congenital or chronic diseases

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, Seoul, 08779, South Korea

Location

Study Officials

• Seoung Hyun Kang

  H Plus Yangji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 10, 2025
• Study Start: June 29, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 9, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)