Pharmacokinetics and bioequivalence study of two ciprofloxacin hydrochloride tablets in healthy Chinese subjects under fasting and fed conditions: A randomized, open-label, two-formulation, two-sequence, two-period, single-dose crossover study

Abstract

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).

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

“…Our laboratory has long been engaged in bioequivalence studies of generic drugs. 21 Recently, Chen et al 22 summarized the food effects on rosuvastatin pharmacokinetics in Chinese healthy subjects through four bioequivalence studies, and the study results revealed that administration after food intake caused an approximately 40% decrease in rosuvastatin exposure and a nearly half decrease in rosuvastatin C max . In addition, the results showed that food had no effects on the T max or λz of rosuvastatin.…”