The goal of this clinical trial is to evaluate of bioequivalence between fixed-dose combination and co-administration of the individual components under fasting conditions in healthy Korean volunteers.
40 healthy subjects are administered the corresponding drug for each period, and the drug wash-out period is set to 7 days. Pharmacokinetic samples are collected for up to 36 hours. Pharmacokinetic parameters are compared to evaluate bioequivalence, and additionally, safety are evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
QD, PO
QD, PO
Samik Pharmaceutical Co. Ltd.
Incheon, South Korea
AUCt of SIPS-2209-1
AUCt: Area under the concentration-time curve from time zero to time
Time frame: predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
Cmax of SIPS-2209-1
Cmax: Maximum plasma concentration of the drug
Time frame: predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
AUCinf of SIPS-2209-1
AUCinf : AUC from time 0 to infinity
Time frame: predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
CL/F of SIPS-2209-1
CL/F : Clearance
Time frame: predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
Tmax of SIPS-2209-1
Tmax : Time to maximum plasma concentration of drug
Time frame: predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
t1/2 of SIPS-2209-1
t1/2 : Terminal half-life
Time frame: predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
Vd/F of SIPS-2209-1
Vd/F : Volume of distribution based on the terminal phase
Time frame: predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
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