This study was designed to compare bioequivalence of the Test Product Clopidogrel bisulfate, film-coated tablets, 75 mg (JSC Farmak, Ukraine) and Reference Product Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France) in healthy male and female volunteers under fasting conditions.
An open, comparative, randomized, four-period, two- sequence, two-way crossover clinical trial to evaluate the Bioequivalence of Single Doses of Test Product Clopidogrel bisulfate, film-coated tablets, 75 mg (JSC Farmak, Ukraine) and Reference Product Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France) in healthy adult male and female volunteers under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
48
One film-coated tablet was administrated orally with 240 ml of water after an overnight fast
One film-coated tablet was administrated orally with 240 ml of water after an overnight fast
Clinical and Diagnostics Center of National University of Pharmacy (NUPh).
Kharkiv, Ukraine
Сmax
maximum plasma concentration observed
Time frame: up to 36 hours post-administration
AUC0-t
area under the plasma concentration versus time curve calculated by the trapezoidal rule from sampling time zero to sampling time of the last measurable plasma concentration
Time frame: up to 36 hours post-administration
tmax
the time of the maximum plasma drug concentration
Time frame: up to 36 hours post-administration
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