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.

BackgroundCipro oxacin is a broad-spectrum uoroquinolone antibiotic which is active against a wide range of Gram-positive and Gram-negative bacteria. The study mainly aimed to determine the bioequivalence of two branded cipro oxacin hydrochloride tablets (250 mg) under the fasting and fed conditions. MethodsThe study was carried out in 48 healthy Chinese subjects under fasting and fed conditions with a randomized, open-label, two-formulation, two-sequence, two-period, single-dose crossover design. In each period of the study, the subjects were assigned to receive a single oral dose of 250 mg of cipro oxacin hydrochloride. Blood samples were collected from an hour before dosing to 36 h after administration with 16 time points in total. The bioequivalence analysis was performed after ln-transformation of the cipro oxacin pharmacokinetic parameters including maximum concentration (C max ), area under the plasma concentration-time curve from time 0 to time t (AUC 0-t ), area under the plasma concentrationtime curve from time 0 to in nity (AUC 0-∞ ). Two formulations are considered bioequivalent if the 90% con dence intervals (CIs) for the test/reference geometric mean ratios (GMRs) for the ln-transformed pharmacokinetic parameters fall within the standard acceptance range of 80% -125%. ResultsIn total of 48 subjects were enrolled in the fasting and fed studies, and one of the subjects was excluded before the administration. In the fasting study, the 90% CIs for the test/reference GMRs of the lntransformed data for C max , AUC 0-t , and AUC 0-∞ were 85.41% to 100.97%, 95.40% to 100.27%, and 95.48% to 100.30%, respectively. For the fed study, the 90% CIs for the test/reference GMRs of the ln-transformed data for C max , AUC 0-t , and AUC 0-∞ were 90.15% to 113.75%, 99.10% to 103.77% and 99.11% to 103.80%, respectively. A total of 8 of 47 subjects experienced AEs in the fasting and fed studies. ConclusionsIn the study, the generic (test) product of cipro oxacin hydrochloride 250 mg was bioequivalent to the innovator (reference) product after a single oral dose administration under the fasting and fed conditions. Both two brands of cipro oxacin tablets were safe and well tolerated. Trial registrationThe clinical trial was registered at Center for the Drug Evaluation of the National Medical Products Administration (registration number: CTR20171152; date of registration September 25, 2017; http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml).