Bioequivalence of citalopram in Chinese healthy volunteers

VernacularTitle:西酞普兰片在中国健康受试者的人体生物等效性研究
Author: Peng-Li FAN ¹ ; Ning-Min ZHAO ; Hai-Feng ZHANG ; Ai-Ling MA ; Yi-Meng WANG
Author Information

1. 河南省人民医院药学部
Keywords: citalopram; UPLC-MS/MS; bioequivalence
From: The Chinese Journal of Clinical Pharmacology 2016;32(13):1185-1187
CountryChina
Language:Chinese
Abstract: Objective To study the pharmacokinetics and bioequivalence of two citalopram preparations .Methods Eighteen healthy volunteers were randomly divided into two groups , whose plasma concentrations of citalopram were determined by UPLC -MS/MS method after single oral dose of 20 mg.The pharmacokinetic parameters were calculated by DAS 2.1.Results The main pharmacokinetic parameters of citalopram in test and reference preparations were as follows:tmax were (4.14 ±3.10), (3.53 ±2.05 ) h; Cmax were ( 32.46 ±8.29 ), ( 34.55 ±7.05 ) ng? mL-1;t1/2 were ( 46.99 ±10.72 ) , ( 42.91 ±8.23 ) h; AUC0-t were (1379.83 ±301.72), (1455.61 ±349.93) ng? h? mL-1, respective-ly.The relative bioavailability of citalopram was ( 96.00 ±13.10 )%. Conclusion The method was proved to be accurate , rapid and sensitive;citalopram in the test preparations was bioequivalent to the reference .