Bioequivalence of PREVENTOR (rosuvastatin), film-coated tablets, to the reference product Crestor (rosuvastatin), film-coated tablets
10 September 2019Purpose. To prove the bioequivalence (BE) of the test medicinal product (MP) PREVENTOR, film-coated tablets, 20 mg rosuvastatin, manufactured by PrJSC “Pharmaceutical Firm “Darnitsa” (Ukraine), to the reference MP Crestor, film-coated tablets, 20 mg rosuvastatin, manufactured by AstraZeneca UK Limited (United Kingdom) in a comparative randomized crossover, two-sequence, four-period study (according to the TRTR/RTRT scheme) in healthy volunteers.
Object and methods of the study. Male and female volunteers administered the test and reference MPs at a dose of 20 mg rosuvastatin (80 mg rosuvastatin throughout the study) once on an empty stomach. Blood samples were collected within 72 hours. The plasma concentration of rosuvastatin in volunteers was measured using high-performance liquid chromatography with tandem mass-spectrometric detection (HPLC-MS/MS).
Results. Pharmacokinetic analysis included data from 30 healthy volunteers. Mean Cmax values for PREVENTOR MP and Crestor reference MP were 17.055 ± 12.555 ng/ml and 16.968 ± 11.192 ng/ml, respectively, and mean AUC0-t values were 128.745 ± 67.100 ng*h/ml and 130.877 ± 68.342 ng*h/ml, respectively. 90% confidence intervals limits for the ratio of geometric means of Cmax (91.19%–105.53%) and AUC0-t (93.67%–104.79%) for PREVENTOR and Crestor meet the predefined acceptance criterion (80.00%–125.00%). A total of 6 adverse events (AE) were observed in 4 volunteers. AE relationship with the administration of the study products was unlikely or doubtful and these events were considered non-serious.
Conclusions. The study proved bioequivalence of the generic MP PREVENTOR, film-coated tablets, 20 mg rosuvastatin, to the reference MP Crestor, film-coated tablets, 20 mg rosuvastatin. Both medicinal products were characterized with good tolerability with single (within each period) oral dosage on an empty stomach.
The sponsor of the study, PrJSC “Pharmaceutical Firm “Darnitsa” expresses its gratitude to the employees of PHARMBIOTEST Research Centre LLC (Ukraine) and the bioanalytical laboratory of QUINTA-ANALYTICA s.r.o. (Czech Republic) for conducting the research and processing its results.
Kravchuk Zh.M., Kuznetsov I.E., Kubesh V., Tsapko G.V., Sotnichenko N.M., Doroshenko A.M. Bioequivalence of the drug Preventor (rosuvastatin), film coated tablets, Crestor reference drug (rosuvastatin), film coated tablets, as a result of a randomized cross-sectional clinical study in healthy volunteers. Ukr. Med. Journal, 2019; (132): 69-73.
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