Bioequivalence of galanthamine hydrobromide orally disintegrating tablets and common tablets in healthy volunteers
10.3969/j.issn.1001-6821.2010.04.008
- VernacularTitle:氢溴酸加兰他敏口腔崩解片与普通片在健康人体的生物等效性
- Author:
Su-Xia XIA
1
;
Shi-Liang ZHANG
;
Si TANG
;
Yue-Min WANG
;
Dong-Cai HUANG
Author Information
1. 辽宁省中医药研究院
- Keywords:
galanthamine hydrobromide orally disintegrating tablets;
bioequivalence:LC-MS/MS
- From:
The Chinese Journal of Clinical Pharmacology
2010;26(4):271-274
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the bioequivahnce of a single dose galanthamine hydrobromide orally disintegrating tablets in Chinese healthy volunteers.Methods Twenty healthy volunteers were divided into 2 groups.Twenty mg single oral dose of galanthamine hydrobromide orally disintegrating tablets was given to 20 heahy volunteers.The concentrations of plasma samples collected from the volunteers respectively were determined by LC-MS/MS.The pharmaeokinetie parameters were calaulated by DAS ver 2.1 software.Results The main pharmacokinetic parameters of galanthamine hydrobromide orally disintegrating test and reference tablets were as follows:t_(max) were(1.06±0.81)and(0.85±0.26)h;t_(1/2) were(8.39±1.60)and(8.22±1.58)h;C_(max) were (39.69±8.17)and(43.41±11.58)μg·L~(-1);AUC_(0-t) were (384.88±101.75)and(407.53±101.12)μg·h·L~(-1);AUC_(0-∞)were(396.92±105.85)and(420.10±103.73)μg·h·L~(-1),respectively.The relative bioavailability of drug was(95.5±1 6.2)%.Conclusion The two kinds of galanthamine hydrobromide tablets are bioequivalent.
