Bioequivalence of moxifloxacin hydrochloride tablets in healthy Chinese subjects / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics
; (12): 1393-1399, 2021.
Article
de Zh
| WPRIM
| ID: wpr-1014927
Bibliothèque responsable:
WPRO
ABSTRACT
AIM: To study the pharmacokinetic characteristics of single-dose oral moxifloxacin hydrochloride tablets under fasting and fed conditions, and use moxifloxacin hydrochloride tablets produced by Bayer Pharma AG as a reference to compare the pharmacokinetic parameters of the two preparations, and evaluate the human bioequivalence of the two preparations. METHODS: A single-center, randomized, open, two-period, and self-crossover design was adopted to conduct a fasting and fed bioequivalence study of 23 healthy subjects each. The 0.4 g dose preparations were taken orally per cycle on fasting or fed administration. The plasma concentrations of moxifloxacin at different times after administration were determined by HPLC-MS/MS. The main pharmacokinetic parameters were calculated, and the bioavailability of the test preparation relative to the reference preparation was evaluated. RESULTS: After subjects in the fasting group took the test preparation T and the reference preparation R, the main pharmacokinetic parameters of moxifloxacin hydrochloride were: C
Texte intégral:
1
Base de données:
WPRIM
Langue:
Zh
Journal:
Chinese Journal of Clinical Pharmacology and Therapeutics
Année:
2021
Type de document:
Article