A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP1906 Tab. 5 mg and YHR1902 Tab. 5mg in healthy volunteers
30 healthy subjects will be randomized to one of the 2 groups in the same ratio. Subjects in group 1 will be administered "comparator" and "YHP1906 Tab. 5 mg" by cross-over design on day 1, 8. Subjects in group 2 will be administered "YHP1906 Tab. 5 mg" and "comparator" by cross-over design on day 1, 8
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Metro Hospital
Anyang-si, Gyeonggi-do, South Korea
Area under the plasma drug concentration-time curve [AUCt]
Area under the plasma drug concentration-time curve \[AUCt\] of Apixaban
Time frame: 0-36 hours
Maximum plasma concentration [Cmax]
Maximum plasma concentration \[Cmax\] of Apixaban
Time frame: 0-36 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 Apixaban
Time frame: 0-36 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 Apixaban
Time frame: 0-36 hours
Time of peak concentration [Tmax]
Time of peak concentration \[Tmax\] of Apixaban
Time frame: 0-36 hours
Terminal phase of half-life [t1/2]
Terminal phase of half-life \[t1/2\] of Apixaban
Time frame: 0-36 hours
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