The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation 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
25
Two oral doses (total daily dose of 200 mg)
Single oral dose (total daily dose of 270 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.