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Confirmation of bioequivalence of Vasoclean-Darnitsa, coated tablets, and Liprimar®, film-coated tablets: results of a randomized crossover replicated clinical trial in healthy volunteers

April 25, 2019
919
Artysh B.
Doroshenko A.
Sabko V.
Sotnychenko N.M.
Keywords :
bioequivalence,
generic,
healthy volunteers,
reference drug,
tablets,
аторвастатин
Resume

The aim was to prove the bioequivalence of the test drug product Vasoclean-Darnitsa, atorvastatin 20 mg coated tablets, manufactured by PrJSC «Pharmaceutical Firm «Darnitsa» (Ukraine) and the reference drug product Liprimar®, atorvastatin 20 mg film-coated tablets, manufactured by Pfizer Manufacturing Deutschland GmbH (Germany) in a comparative randomized four-period two-sequence (TRTR/RTRT) crossover clinical trial in healthy volunteers. Materials and methods. Male volunteers took in the fasting condition a single 20 mg atorvastatin dose of the test and reference drugs (80 mg of atorvastatin during the whole study). Blood samples were taken within 48 hours. Quantitative determination of atorvastatin in blood plasma of the volunteers was performed using ultra-performance liquid chromatography with tandem mass selective detection. Results. Data from 37 healthy volunteers were included in the analysis of pharmacokinetics. For Vasoclean-Darnitsa and Liprimar®, mean atorvastatin Cmax values were 6.739±4.276 and 7.172±4.053 ng/mL, respectively, and corresponding mean AUC0–t values were 31.873±28.789 and 29.279±19.311 ng ‧ h/mL, respectively. The ranges of 90% confidence intervals of geometric mean ratio for Cmax (81.15–102.66%) and AUC0–t (94.09–111.09%) for Vasoclean-Darnitsa and Liprimar® meet prespecified acceptance criteria (80.00–125.00%). Suspected adverse reactions were observed in 5 volunteers and were considered to be non-serious. Conclusions. The bioequivalence of Vasoclean-Darnitsa, 20 mg atorvastatin coated tablets, and the reference drug product Liprimar®, 20 mg ator­vastatin film-coated tablets, was proven. Both drugs were well-tolerated following a single dose oral administration in the fasting state.

Published: 24.04.2019

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