Pharmacokinetics and bioequivalence evaluation of ciprofloxacin tablets in healthy Chinese subjects under fasting and fed conditions / 中国临床药理学与治疗学

AIM: To evaluate the pharmacokinetic properties and bioequivalence of two ciprofloxacin tablets in healthy Chinese subjects under fasting and fed conditions. METHODS: This is a randomized, open-label, two-period crossover study. Subjects were randomized to receive a single oral dose of the ciprofloxacin test or reference formulations 250 mg under fasting and fed conditions. Human plasma concentrations were determined using a liquid chromatography tandem mass spectrometry method (LC-MS/MS). A non-compartmental method by Phoenix WinNonlin 8.0 software was used for calculating pharmacokinetic parameters and evaluating bioequivalence of the two formulations. RESULTS: A total of 26 healthy subjects were enrolled the study under fasting conditions and completed it. The pharmacokinetic parameter values of the test and reference formulation under fasting conditions were as follows: C

In-vitro bioequivalence, physicochemical and economic benefits study for marketed innovator and generic ciprofloxacin hydrochloride tablets in Saudi Arabia.

The objective of the present study was to compare and evaluate the economic benefits and in-vitro bioequivalence of different marketed generic ciprofloxacin tablets against the innovator tablet formulation that are present in the local market of Saudi Arabia. The comparative bioequivalence and physicochemical study of five ciprofloxacin marketed tablets were performed through the assessment of the uniformity of weight, hardness, disintegration, dissolution, and content assay of the products. In order to compare the dissolution profiles of all generic tablet formulations and the innovator, a model independent approach of similarity factor (f2) and difference factor (f1) was employed in the in vitro dissolution studies. Deviations were noted in two generic products, these deviations caused significant differences in disintegration time and dissolution profile in only one of the generic products. All tested generic products passed USP monograph dissolution testing except one product which failed to pass both similarity factor (f2) and difference factor (f1) tests required by FDA bioequivalence testing. The majority of generic products in Saudi Arabia which had lower prices showed comparable quality to innovator.