Pharmacokinetics and bioequivalence evaluation of ciprofloxacin tablets in healthy Chinese subjects under fasting and fed conditions
10.12092/j.issn.1009-2501.2021.11.008
- Author:
Lu WANG
1
;
Zourong RUAN
1
;
Dandan YANG
1
;
Rong SHAO
1
;
Bo JIANG
1
;
Kaiwen ZHANG
2
;
Jing CHEN
2
Author Information
1. Center of Clinical Pharmacology, The Second Affiliated Hospital, Zhejiang University School of Medicine
2. Research Institute of Zhejiang Pharmaceutical Co., Ltd
- Publication Type:Journal Article
- Keywords:
Bioequivalence;
Ciprofloxacin tablets;
Healthy Chinese subjects;
Pharmacokinetics
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2021;26(11):1273-1278
- CountryChina
- Language:Chinese
-
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
