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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06926387

Enrollment

Registered

2025-04-13

Start date

2025-04-17

Completion date

2025-04-29

Last updated

2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Pharmacokinetics, Bioequivalence

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

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.

Interventions

DRUGYHP2407

Test drug: YHP2407, Comparator: YHR2502

DRUGYHR2502

Test drug: YHP2407, Comparator: YHR2502

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 64 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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 from time 0 to infinity \[AUCinf\] of Cefaclor Hydrate
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	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
Time of peak concentration [Tmax]	0-6 hours	Time of peak concentration \[Tmax\] of Cefaclor Hydrate
Terminal phase of half-life [t1/2]	0-6 hours	Terminal phase of half-life \[t1/2\] of Cefaclor Hydrate

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026