Bioequivalence of norfloxacin tablets in Chinese Healthy volunteers under Fasting and Fed Condition / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics
;
(12): 1357-1362, 2020.
Artículo
en Chino
| WPRIM
| ID: wpr-1015112
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
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Idioma:
Chino
Revista:
Chinese Journal of Clinical Pharmacology and Therapeutics
Año:
2020
Tipo del documento:
Artículo
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