The primary objective of this trial is to test whether Pletal ODT administered without water can be considered bioequivalent to Pletal administered with 200 ml water (both treatments being administered after fasting and at least 30 minutes prior to receiving a light breakfast) based on the standard pharmacokinetic variables. The secondary objective is to assess the effect of water and the effect of food on the administration of Pletal ODT based on standard pharmacokinetic variables.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
100 mg Cilostazol
AAIPharma Deutschland GmbH & Co. KG
Neu-Ulm, Germany
Area under the curve, maximal concentration (Cmax)
Time frame: 1-2 months
Time of maximum (tmax), Vss/f, CL/f)
Time frame: 1-2 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.