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
63
H Plus Yangji Hospital
Seoul, South Korea
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
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
Time frame: 0-8 Hours
Terminal phase of half-life [t1/2]
Terminal phase of half-life \[t1/2\] of Amoxicillin \& Clavulanic acid
Time frame: 0-8 Hours
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