Bioequivalence of the medicinal product Preventor (rosuvastatin), film-coated tablets, to the reference medicinal product Crestor® (rosuvastatin), film-coated tablets, in a randomized crossover clinical trial in healthy volunteers

September 3, 2019
607
Resume

The aim is to prove the bioequivalence of the test medicinal product Preventor, 20 mg rosuvastatin film-coated tablets, manufactured by PrJSC «Pharmaceutical Firm «Darnitsa» (Ukraine) and the reference medicinal product Crestor®, 20 mg rosuvastatin film-coated tablets, manufactured by «AstraZeneca UK Limited» (United Kingdom) in a comparative randomized four-period two-sequence (TRTR/RTRT) crossover clinical trial in healthy volunteers. Materials and methods. Male and female volunteers took in the fasting condition a single 20 mg rosuvastatin dose of the test or reference medicinal product (80 mg of rosuvastatin during the whole study). Blood samples were taken within 72 hours. Quantitative determination of rosuvastatin in blood plasma of the volunteers was performed using high-performance liquid chromatography with tandem mass selective detection. Results. Data from 30 healthy volunteers were included in the analysis of pharmacokinetics. For Preventor and Crestor®, mean rosuvastatin Cmax values were 17.055±12.555 and 16.968±11.192 ng/mL, respectively, and corresponding mean AUC0–t values were 128.745±67.100 and 130.877±68.342 ng‧h/mL, respectively. The ranges of 90% confidence intervals of geometric mean ratio for Cmax (91.19–105.53%) and AUC0–t (93.67–104.79%) for Preventor and Crestor® meet prespecified acceptance criteria (80.00–125.00%). Six adverse events were reported in 4 volunteers. Adverse events were unlikely or doubtly related to study treatment and were considered to be non-serious. Conclusions. The bioequivalence of generic medicinal product Preventor, 20 mg rosuvastatin film-coated tablets, and the refe­rence medicinal product Crestor®, 20 mg rosuvastatin film-coated tablets, was proven. Both drugs were well-tolerated following a single dose (within each period) oral administration in the fasting state.

Published: 03.09.2019
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