%0 Journal Article
%T Pharmacokinetics and Bioequivalence Evaluation of Two Rosuvastatin Calcium 20 mg Tablets: A Single Oral Dose, Randomized-Sequence, Open-Label, Two-Period Crossover Study in Healthy Volunteers under Fasting Conditions
%A Evelyn Pena
%A Alfredo Inatti
%A Jos¨¦ Gregorio Chac¨®n
%J Journal of Biosciences and Medicines
%P 230-243
%@ 2327-509X
%D 2024
%I Scientific Research Publishing
%R 10.4236/jbm.2024.126020
%X <b>Objectives</b>: To compare the rate and extent of absorption of Racor® 20 mg (Rosuvastatin calcium 20 mg) tablet of Laboratorios Leti, S.A.V., with Crestor® 20 mg (Rosuvastatin calcium 20 mg) tablet of AstraZeneca, UK Limited in healthy adult human subjects under fasting conditions. <b>Method</b>: This was an open label, analyst blind, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study in healthy, adult, human subjects under fasting condition. Twenty-four (24) subjects were planned as per the protocol and all subjects completed both periods of the study. The concentrations of Rosuvastatin in plasma were quantitated using a validated LC-MS/MS method of analysis and plasma levels were submitted for statistical analysis. C<sub>max</sub>, AUC<sub>0-t</sub>, AUC<sub>0-¡̃</sub>, T<sub>max</sub>, t1/2, Kel (hrs<sup>-1</sup>), percent AUC extrapolated [100 * (AUC<sub>0-¡̃</sub> - AUC<sub>0-t</sub>)/AUC<sub>0-¡̃</sub>] (AUC_%Extrapobs) were calculated for rosuvastatin in plasma using SAS® version 9.1.3, SAS Institute. Inc. USA.CARY. ANOVA, 90% confidence interval using Schuirmann¡¯s two one-sided test for bioequivalence, power and ratio analysis, for lntransformed pharmacokinetic parameters C<sub>max</sub>, AUC<sub>0-t</sub> and AUC<sub>0-¡̃</sub> were computed and reported for Rosuvastatin in plasma for BE. <b>Results</b>: Data showed that 90% confidence intervals for the test/reference geometric mean ratios (GMR) of C<sub>max</sub> (95.01 - 112.66), AUC<sub>0-t</sub> (93.38 - 111.67) and AUC<sub>0-¡̃</sub> (93.65 - 111.29) were within the BE (80% - 125%) acceptance range. <b>Conclusions</b>: Two products formulation, reference (R) Crestor® (rosuvastatin calcium) of AstraZeneca and test (T), Racor® (rosuvastatin calcium) of Laboratorios Leti S.A.V., with a single dose of 20 mg, under fasting conditions were bioequivalent. No severe, serious or unexpected adverse events (AEs) were reported in this study.
%K Bioequivalence
%K Rosuvastatin
%K Pharmacokinetics
%U http://www.scirp.org/journal/PaperInformation.aspx?PaperID=134046