PDF
Full
Outline
To analyze the bioequivalence and safety of the test and reference formulations of erlotinib hydrochloride tablets in healthy Chinese subjects under fasting conditions following a single oral dose.
The study was conducted as a randomized, open-label, two-period crossover trial. A total of 60 healthy subjects were assigned to two sequences by randomization. Under fasting conditions, subjects received a single 150 mg oral dose of either the test or reference formulation, with a 12-day washout period between doses. The plasma concentrations of erlotinib were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS), and the pharmacokinetic parameters were calculated for bioequivalence evaluation using Phoenix WinNonlin software (version 8.3).
After a single oral administration of the test or reference formulation under fasting conditions, the main pharmacokinetic parameters of erlotinib hydrochloride were as follows: maximum concentration (Cmax) was (1 649.48±567.44) and (1 548.15±529.59) ng·mL-1, AUC0-last were (28 830.12±11 507.57) and (29 396.47±11 121.61) h·ng·mL-1, AUC0-inf were (30 759.13±13 789.60) and (31 132.78±12 912.53) h·ng·mL-1. The 90% confidence intervals for the geometric mean ratios of Cmax, AUC0-last, and AUC0-inf for the two formulations were 92.44%-117.31%, 87.65%-103.90% and 87.66%-104.37%, respectively, all of which were within the bioequivalence acceptance range of 80.00%-125.00%. No serious adverse events, suspected unexpected serious adverse reactions, or adverse events leading to withdrawal occurred during the trial.
Under fasting conditions, the test erlotinib hydrochloride tablets were bioequivalent to the reference listed drug Tarceva® in healthy Chinese subjects and the safety profile was favorable.
PDF
215
40
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
关闭全屏
No. 86 Xueyuan South Road, Haidian District, Beijing
010-62199257
qkjq@cast.org.cn
Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House
