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

摘要

Objective: The study mainly aimed to determine the bioequivalence of two branded ciprofloxacin hydrochloride tablets (250 mg) under fasting and fed conditions. Materials and methods: The 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 ciprofloxacin hydrochloride. Blood samples were collected from 1 hour before dosing to 36 hours after administration with 16 time points in total. The bioequivalence analysis was performed after ln-transformation of the ciprofloxacin pharmacokinetic parameters including C-max , AUC(0-t) , and AUC(0-infinity). Results: A total of 48 subjects were enrolled in the fasting and fed studies, and 1 of the subjects was excluded before drug administration. In the fasting study, the 90 CIs for the test/ reference geometric mean ratios (GMRs) of the ln-transformed data for C-max , AUC(0-t) , and AUC(0-infinity) were 85.41 - 100.97, 95.40 - 100.27, and 95.48 - 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-infinity) were 90.15 - 113.75, 99.10 - 103.77, and 99.11 - 103.80, respectively. These values all fell within the standard acceptance range of 80 - 125. Conclusion: In the study, the generic (test) product of ciprofloxacin hydrochloride 250 mg was bioequivalent to the innovator (reference) product after single-, oral-dose administration under fasting and fed conditions.