Bioequivalence study of cetirizine hydrochloride tablets under fasting and fed conditions
10.12092/j.issn.1009-2501.2020.12.007
- Author:
Chaoying HU
1
;
Dan GAO
1
;
Linyan GAO
1
;
Lin LI
1
;
Lan ZHANG
1
;
Yanfei WAN
2
;
Bei GAO
2
Author Information
1. Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, National Clinical Research Center for Geriatric Diseases
2. Chengdu Leer Pharmaceutical Co., Ltd
- Publication Type:Journal Article
- Keywords:
Bioequivalence;
Cetirizine;
LC-MS/MS;
Pharmacokinetic
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2020;25(12):1363-1368
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To evaluate the pharmacokinetics and bioequivalence of cetirizine hydrochloride tablets under fasting and fed conditions in Chinese healthy subjects. METHODS: This was a randomized, open-label, double-sequence, two-period, crossover designed study, and healthy subjects enrolled and administrated a single dose of 10 mg test and reference cetirizine hydrochloride tablets in each period under fasting or fed condition. The plasma concentrations of cetirizine were determined by a validated LC-MS/MS method. The pharmacokinetic parameters were calculated with WinNonlin 6.3 and the bioequivalence was evaluated through SAS 9.4 software. RESULTS: In the fasting condition, the major pharmacokinetic parameters of cetirizine of test and reference formulations were as follows, C
