Bioequivalence Study betweenYHP2407 and YHR2502 in Healthy Subjects

NCT06926387 | Completed Phase 1

• 1 other identifier: YHP2407-101
• Study Type: interventional
• Target: 43
• 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 YHP2407 and YHR2502 in healthy volunteers

Conditions

Healthy Volunteer

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 Cefaclor Hydrate

  0-6 hours

• Maximum plasma concentration [Cmax]

  Maximum plasma concentration \[Cmax\] of Cefaclor Hydrate

  0-6 hours

Secondary Outcomes (4)

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

  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]

  0-6 hours

• Time of peak concentration [Tmax]

  0-6 hours

• Terminal phase of half-life [t1/2]

  0-6 hours

Study Arms (2)

A(RT)

EXPERIMENTAL

20 subjects, Cross-over, Single dose YHR2502 on period 1, Single dose of YHP2407 on period 2

Drug: YHP2407; Drug: YHR2502

B(TR)

EXPERIMENTAL

20 subjects, Cross-over, Single dose of YHP2407 on period 1, Single dose of YHR2502 on period 2

Drug: YHP2407; Drug: YHR2502

Interventions

YHP2407 DRUG

Test drug: YHP2407, Comparator: YHR2502

A(RT); B(TR)

YHR2502 DRUG

Test drug: YHP2407, Comparator: YHR2502

A(RT); B(TR)

Eligibility Criteria

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

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)

Gimpo Woori Hospital

Gimpo-si, Gyeonggi-do, 10099, South Korea

Location

Study Officials

• Hyejin Lim

  Gimpo Woori 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: April 6, 2025
• First Posted: April 13, 2025
• Study Start: April 17, 2025
• Primary Completion: April 19, 2025
• Study Completion: April 29, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)