PDF
Full
Outline
To investigate the bioequivalence of oral torasemide tablets in healthy subjects under fasting and postprandial states.
A single-center, randomized, open-label, single-dose, double-period, double-cross study design was adopted. Each period involved a single oral administration of 10 mg of torasemide under fasting or postprandial conditions. The plasma drug concentration of torasemide was determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The pharmacokinetic data were calculated and bioequivalence evaluation was performed.
The pharmacokinetic parameters of the test formulation and reference formulation in the fasting group were as follows: Cmax were (1 664.91±353.89) and (1 645.29±363.80) ng·mL-1, AUC0-t were (3 459.38±659.07) and (3 468.21±616.06) h·ng·mL-1, AUC0-∞ were (3 637.12±700.25) and (3 644.48±651.24) h·ng·mL-1. The pharmacokinetic parameters of the test formulation and reference formulation in the postprandial group were as follows: Cmax were (1 018.18±336.79) and (883.97±172.43) ng·mL-1, AUC0-t were (3 974.56±963.76) and (3 924.70±943.83) h·ng·mL-1, AUC0-∞ were (4 192.17±1081.81) and (4 143.90±1068.71) h·ng·mL-1; the 90% confidence intervals of the ratios of the pharmacokinetic parameters of the test formulation and reference formulation (test formulation/reference formulation) under fasting and postprandial conditions were all within the statistically equivalent range.
Torasemide tablets test formulation and the reference formulation have bioequivalence under both fasting and postprandial administration conditions.
PDF
179
65
| 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
