Bioequivalence of Vazoklin-Darnitsa, film-coated tablets, to Liprimar® film-coated tablets20 April 2019
Purpose. to prove the bioequivalence (BE) of Vazoklin-Darnitsa, film-coated tablets, 20 mg atorvastatin, manufactured by PrJSC “Pharmaceutical Firm “Darnitsa” (Ukraine), to the reference medicinal product Liprimar®, film-coated tablets, 20 mg atorvastatin, manufactured by Pfizer Manufacturing Deutschland GmbH (Germany) 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 volunteers administered the test and reference medicinal products at a dose of 20 mg atorvastatin (80 mg atorvastatin throughout the study) once on an empty stomach. Blood samples were collected within 48 hours. The plasma concentration of atorvastatin in volunteers was measured using ultra-performance liquid chromatography with tandem mass-spectrometric detection (UPLC-MS/MS).
Results. Pharmacokinetic analysis included data from 37 healthy volunteers. Mean Cmax values for the test medicinal product Vazoklin-Darnitsa and the reference medicinal product Liprimar® were 6.739±4.276 ng/ml and 7.172±4.053 ng/ml, respectively, and mean AUC0-t values were 131.873±28.789 ng h/ml and 29.279±19.311 ng h/ml, respectively. 90% confidence interval limits for the ratio of geometric means of Cmax (81.15%–102.66%) and AUC0–t (94.09%–111.09%) for Vazoklin-Darnitsa and Liprimar® meet the predefined acceptance criterion (80.00%–125.00%). The suspected adverse reactions (AR) were observed in 5 volunteers and were considered non-serious.
Conclusions. The study proved bioequivalence of Vazoklin-Darnitsa, film-coated tablets, 20 mg atorvastatin, to Liprimar® film-coated tablets, 20 mg atorvastatin. Both medicinal products were characterized with good tolerability with single oral dosage on an empty stomach.
The sponsor of the study, PrJSC “Pharmaceutical Firm “Darnitsa” expresses its gratitude to the employees of the medical centre INNOPHAR – Ukraine Innovative Pharma Research Clinic LTD (Ukraine) and the bioanalytical laboratory of Clinfarm LLC (Ukraine) for conducting the research and processing its results.