Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects

Phase 1CompletedNCT06920719

Yuhan Corporation64 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Subject

Interventions

YHP2406DRUG

Test drug: YHP2406, Comparator: YHR2501

YHR2501DRUG

Test drug: YHP2406, Comparator: YHR2501

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

H Plus Yangji Hospital

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

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

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

Time frame: 0-8 hours

Maximum plasma concentration [Cmax]

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

Time frame: 0-8 hours

Secondary Outcomes

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

Area under the plasma drug concentration-time curve from time 0 to infinity \[AUCinf\] of Amoxicillin \& Clavulanic acid

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]

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

Time frame: 0-8 Hours

Time of peak concentration [Tmax]

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

Time frame: 0-8 Hours

Terminal phase of half-life [t1/2]

Terminal phase of half-life \[t1/2\]

Time frame: 0-8 Hours

Data from ClinicalTrials.gov

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