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

ABSTRACT

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