Healthy Subject
Conditions
Keywords
Pharmacokinetics, Bioequivalence
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
Detailed description
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.
Interventions
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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] | 0-8 hours | Area under the plasma drug concentration-time curve \[AUCt\] of Amoxicillin & Clavulanic acid |
| Maximum plasma concentration [Cmax] | 0-8 hours | Maximum plasma concentration \[Cmax\] of Amoxicillin & Clavulanic acid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 from time 0 to infinity \[AUCinf\] of Amoxicillin & Clavulanic acid |
| 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 | 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 of peak concentration [Tmax] | 0-8 Hours | Time of peak concentration \[Tmax\] of Amoxicillin & Clavulanic acid of Amoxicillin & Clavulanic acid |
| Terminal phase of half-life [t1/2] | 0-8 Hours | Terminal phase of half-life \[t1/2\] |
Countries
South Korea
Outcome results
None listed