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To evaluate the bioequivalence of domestic bromhexine hydrochloride granules and imported bromhexine hydrochloride fine granules in Chinese healthy subjects under fasting and fed states.
A single-center, randomized, open-label, fasting and fed single-dose, two-preparation, two-sequence, and two-period crossover study design was used. Forty-eight Chinese healthy subjects were enrolled in fasting and fed trial, respectively. A random crossover, single-dose of bromhexine hydrochloride granules 0.4 g(containing 8 mg bromhexine) or bromhexine hydrochloride fine granules 0.4 g (containing 8 mg bromhexine) were orally given to subjects. Blood samples were collected at different time points, and plasma concentrations of bromhexine were measured by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Phoenix WinNonlin 8.3 software was used for data analysis.
In the fasting group, the main pharmacokinetic parameters of bromhexine in plasma after taking the test and reference preparations: Cmax were (18.29±7.80) and (19.92±10.23) ng·mL-1, AUC0-t were (31.52±12.23) and (32.22±12.32) ng·h·mL-1, AUC0-∞ were (34.43±13.60) and (34.84±13.36) ng·h·mL-1, respectively. In the fed group, the main pharmacokinetic parameters of bromhexine in plasma after taking the test and reference preparations: Cmax were (12.55±6.27) and (12.64±6.51) ng·mL-1, AUC0-t were (58.86±24.38) and (60.60±26.44) ng·h·mL-1, AUC0-∞ were (68.27±30.76) and (94.01±113.13) ng·h·mL-1, respectively. The 90% confidence intervals of the geometric mean ratio of the two preparations in fasting group: Cmax was 88.79%-101.49%, AUC0-t was 93.69%-102.15%, AUC0-∞ was 94.59%-102.95%; in fed group: Cmax was 93.08%-106.82%, AUC0-t was 94.30%-102.80%, AUC0-∞ was 92.97%-103.89%.
In this study, the test preparation bromhexine hydrochloride granules and the reference preparation bromhexine hydrochloride fine granules were bioequivalent in healthy Chinese subjects.
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| 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 |
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