A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions
To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg, Anpl-one SR Tab. 300mg (Reference) and generic Sarpogrelate HCl 300mg (Test), after a single oral dose administration in healthy volunteers under fasting condition: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets
Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets
Daewoong pharmatceutical
Seoul, Gangnam-gu, South Korea
Maximum Plasma Concentration
Cmax
Time frame: 0-24hr
Area under the plasma concentration versus time curve
AUC
Time frame: 0-24hr
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