PDF
Full
Outline
To evaluate the bioequivalence of test preparation (T) and reference preparation (R) of diphenidol hydrochloride tablets taken orally in a single fasting/postprandibular state in healthy Chinese subjects.
This protocol was designed as random, open, single-center, single-dose, double-cycle and double-cross experiment was selected in this study. A total of 66 healthy male and female subjects were enrolled, including 24 subjects in the test group and 42 subjects in the reference group. All subjects took the test preparation and the reference preparation 25 mg in each cycle. The plasma concentration of diphenidol hydrochloride was determined by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS), and the pharmacokinetic (PK) data collected was analyzed and processed statistically.
The PK parameters of diphenidol hydrochloride tablets and reference preparations in fasting group were as follows: Cmax were (75.90±34.60) and (67.96±19.90) ng·mL-1, respectively; AUC0-t were (387.67±198.48) and (341.57±137.05) ng·h·mL-1, respectively; AUC0-∞ were (413.00±228.39) and (361.70±161.19) ng·h·mL-1, respectively. Main PK parameters of diphenidol hydrochloride tablets and reference preparations orally taken by subjects after meals: Cmax were (92.60±33.60) and (85.30±31.96) ng·mL-1, respectively; AUC0-t were (511.90±206.87) and (498.33±197.78) ng·h·mL-1, respectively; AUC0-∞ were (543.21±236.90) and (513.98±203.92) ng·h·mL-1, respectively. Under fasting and postprandial conditions, subjects took diphenidol hydrochloride tablet and reference preparation orally, one tablet 25 mg each time. The geometric mean of the main pharmacokinetic parameters of difenidol in plasma (Cmax, AUC0-t, AUC0-∞) and the ratio of their corresponding parameters ranged from 80.00% to 125.00% with 90% confidence interval, and no serious adverse events occurred in both groups.
Diphenidol hydrochloride tablets show bioequivalence and good safety evaluation under fasting and postprandial conditions
PDF
0
0
| 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
