Pharmacokinetics and Bioequivalence of Two Formulations of Rosuvastatin Following Single‐dose Administration in Healthy Chinese Subjects Under Fasted and Fed Conditions

Abstract

The main objective of the study was to evaluate the bioequivalence of two rosuvastatin calcium tablets in healthy Chinese subjects under fasted and fed conditions. The study was carried out using a randomized, open‐label, two‐formulation, two‐sequence, two‐period, single‐dose crossover design, with a washout period of 7 days. Both the fasted study and fed study enrolled 28 subjects. In each study period, the subjects were administrated a single oral dose of the test product or reference product of rosuvastatin 10 mg. Blood samples were collected from pre‐dose to 72 hours after administration with 16 time points in total. Bioequivalence evaluation was performed using ln‐transformed pharmacokinetic parameters of rosuvastatin, including Cmax, AUC0–t, and AUC0–∞. In the present study, 95% confidence intervals (CIs) of test/reference geometric mean ratios (GMRs) of Cmax, AUC0–t, and AUC0–∞ under the fasted and fed conditions were all within the acceptance range of 80%–125%. Additionally, only one subject experienced one adverse event (AE). High‐fat meals reduced the Cmax, AUC0–t, and AUC0–∞, but had no significant effects on the λz, t1/2, or Tmax of rosuvastatin. In the current study, the test product was bioequivalent to the reference product, and a single dose of rosuvastatin (10 mg) was well‐tolerated. Food decreased the systemic exposure of rosuvastatin without the effects on the Tmax or elimination rate.

Prognostic value of the platelet, neutrophil, monocyte, basophil, and eosinophil to lymphocyte ratios in patients with severe community-acquired pneumonia (SCAP)

“…The normal distribution of continuous data was determined using the Kolmogorov-Smirnov test. For continuous clinical data with an abnormal distribution, the clinical data are described as medians (interquartile range, IQR), the comparison between independent groups was performed by Mann-Whitney U test 15 , and the comparison between paired samples was performed using Wilcoxon signed rank test 16 . In addition, the correlation between the continuous clinical data was determined using Spearman's correlation coe cient.…”

Platelet-to-Lymphocyte Ratio (PLR), Neutrophil-to-Lymphocyte Ratio (NLR), Monocyte-to-Lymphocyte Ratio (MLR), and Eosinophil-to-Lymphocyte Ratio (ELR) as Biomarkers in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

“…The comparison of continuous data between independent groups was performed by Mann–Whitney U -test, and the paired comparison of the continuous data between groups was performed using the Wilcoxon signed rank test. 27 , 28 The comparison of categorical variables between independent groups was performed using Chi-Square test or Fisher’s exact test. In addition, the comparison of the continuous data among multiple independent groups was performed using the Kruskal–Wallis test.…”