The study is designed to evaluate the bioequivalency between the test formulations of extended-release tablet of cilostazol (PMR) administered once-daily and the reference formulation of immediate-release tablet of cilostazol (Cilostazol) administered twice-daily in normal healthy male and female subjects under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
One immediately-release tablet (Cilostazol 100 mg) at 08:00 and another at 20:00, twice daily oral dose (total daily dose of 200 mg)
Two extended-release tablets (PMR 150 mg) at 08:00, single oral dose (total daily dose of 300 mg)
Two extended-release tablets (PMR 200 mg/tablet) at 08:00, single oral dose (total daily dose of 400 mg)
Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, United States
Area under the curve, from time zero to last measureable time point (AUC (0-t))
Time frame: 0-72 hours after morning dose
AUC from time zero to infinity (AUC (0-∞))
Time frame: 0-72 hours after morning dose
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