Bioequivalence of norfloxacin tablets in Chinese Healthy volunteers under Fasting and Fed Condition
10.12092/j.issn.1009-2501.2020.12.006
- Author:
Dandan YANG
1
;
Jinliang CHEN
1
;
Honggang LOU
1
;
Zourong RUAN
1
;
Bo JIANG
1
;
Jinlian WU
2
;
Jing CHEN
2
Author Information
1. Center of Clinical Pharmacology, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
2. Research Institute of Zhejiang Pharmaceutical Co., Ltd.
- Publication Type:Journal Article
- Keywords:
Bioequivalence;
LC-MS/MS;
Norfloxacin;
Pharmacokinetics
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2020;25(12):1357-1362
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To compare the bioavailability of norfloxacin tablets produced by Zhejiang Pharmaceutical Co., Ltd with the original product BACCIDAL, and to evaluate bioequivalence of two formulations, a randomized, open, two-cycle, self-crossing trial in healthy Chinese population was designed. METHODS: Under fasting and fed conditions, healthy volunteers were given a single dose of norfloxacin test or reference tablets for 100 mg. Liquid chromatography-mass spectrometry (LC-MS/MS) method were used to determine drug concentration in the plasma taken at different time points before and after dosing. Pharmacokinetic parameters and the bioequivalence of the two formulations were calculated by WinNonlin 7.0 software. RESULTS: A total of 28 healthy volunteers were enrolled and completed the fasting test. The pharmacokinetic parameters for test and reference preparations in fasting state were as follows: C
