Bioequivalence of lamotrigine tablets in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2024.06.023
- VernacularTitle:拉莫三嗪片在中国健康受试者中的生物等效性的研究
- Author:
Jin-Sheng JIANG
1
,
2
;
Hong-Ying CHEN
;
Jun CHEN
;
Yao CHEN
;
Kai-Yi CHEN
;
Xue-Hua ZHANG
;
Jie HU
;
Xin LIU
;
Xin-Yi HUANG
;
Dong-Sheng OUYANG
Author Information
1. 中南大学湘雅医院临床药理研究所,湖南长沙 410001
2. 三金集团湖南三金制药有限责任公司,湖南常德 415000
- Keywords:
lamotrigine;
pharmacokinetics;
bioequivalence;
liquid chromatography-tandem mass spectrometry
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(6):894-898
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the pharmacokinetic characteristics of lamotrigine tablets in Chinese healthy subjects under fasting and fed conditions,and to evaluate the bioequivalence and safety profiles between the domestic test preparation and the original reference preparation.Methods Twenty-four Chinese healthy male and female subjects were enrolled under fasting and fed conditions,18 male and 6 female subjects under fasting conditions,17 male and 7 female subjects under fed conditions.A random,open,single-dose,two preparations,two sequences and double-crossover design was used.Plasma samples were collected over a 72-hour period after give the test or reference preparations 50 mg under fasting and fed conditions.The concentration of lamotrigine in plasma was detected by liquid chromatography-tandem mass spectrometry,and the main pharmacokinetic parameters were calculated to evaluate the bioequivalence by WinNonLin 8.1 program.Results The main pharmacokinetic parameters of single-dose the tested and reference preparations were as follows:The fasting condition Cmax were(910.93±248.02)and(855.87±214.36)ng·mL-1;tmax were 0.50(0.25,4.00)and 1.00(0.25,3.50)h;t1/2 were(36.1±9.2)and(36.0±8.2)h;AUC0_72h were(27 402.40±4 752.00)and(26 933.90±4 085.80)h·ng·mL-1.The fed condition Cmax were(701.62±120.67)and(718.95±94.81)ng·mL-1;tmax were 4.00(1.00,5.00)and 4.00(0.50,5.00)h;t1/2 were(44.2±12.4)and(44.0±12.0)h;AUC0-72h were(30 253.20±7 018.00)and(30 324.60±6 147.70)h·ng·mL-1.The 90％confidence intervals of the geometric mean ratios of Cmax and AUC0-72 hfor the test preparation and reference preparation were all between 80.00％and 125.00％under fasting and fed conditions.Conclusion Two kinds of lamotrigine tablets are bioequivalent,and have similar safety in Chinese healthy male and female subjects under fasting and fed conditions.
