Bioequivalence study of desloratadine tablets in healthy Chinese subjects
10.13699/j.cnki.1001-6821.2025.02.014
- VernacularTitle:地氯雷他定片在中国健康受试者的等效性研究
- Author:
Peng-fei XIE
1
;
Yuan-lu CHEN
;
Hong-di CUI
;
Hui LONG
;
Yong-gang ZHAO
;
Qi-shan HUANG
;
Peng YANG
;
Yan ZHOU
;
Yong-dong ZHANG
Author Information
1. 郴州市第一人民医院Ⅰ期临床研究室,湖南郴州 423000
- Publication Type:Journal Article
- Keywords:
desloratadine tablet;
healthy Chinese subject;
pharmacokinetic;
bioequivalence
- From:
The Chinese Journal of Clinical Pharmacology
2025;41(2):220-224
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the pharmacokinetic(PK)characteristics of desloratadine tablets and reference drugs in healthy subjects,and evaluate their bioequivalence and safety.Methods The random,open,two-period,cross-over pharmacokinetic study method was adopted,each subject received a single oral dose of desloratadine tablets test drug(T)or reference drug(R)for 5 mg.The concentrations of desloratadine and 3-hydroxy desloratadine in plasma were determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS);and the PK parameters were calculated by WinNonlin 8.1 software to evaluate the bioequivalence.Results The main PK parameters of T and R of desloratadine were as follows:the fasting condition Cmax were respectively(3 809.82±1 016.54)and(3 642.36±777.07)pg·mL-1;AUC0-120h were respectively(5.75 ×104±5.03 ×104)and(5.51 × 104±4.00 × 104)pg·h·mL-1;AUC0-∞ were respectively(6.85× 104±1.03× 104)and(6.37 × 104±7.92 × 104)pg·h·mL-1.The fed condition Cmax were respectively(4 398.98±1 191.22)and(4 744.4±1 511.97)pg·mL-1;AUC0-120h were respectively(5.25 × 104±1.82 × 104)and(5.55 × 104±1.98 × 104)pg·h·mL-1;AUC0-∞ were respectively(5.37 × 104±1.86 × 104)and(5.68 × 104±2.04 × 104)pg·h·mL-1.The 90％confidence interval of Cmax,AUC0-t and AUC0-∞ of desloratadine were all within 80.00％～125.00％.Conclusion There was no significant difference in the main PK parameters between T tablets and R under fasting or high-fat postprandial conditions,and desloratadine tablets were bioequivalent,safe and well tolerated.
