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To evaluate the bioequivalence of domestic duloxetine hydrochloride enteric-coated tablets and original enteric-coated capsules in Chinese healthy subjects.
In a random, open, two periods, two sequence, self-crossover study, 40 cases healthy subjects in fasting test and 48 cases healthy subjects in fed test were given single oral test preparation and reference preparation 20 mg of duloxetine hydrochloride. The concentrations of duloxetine hydrochloride in plasma were determined by high performance liquid chromatography tandem mass spectrometry. The pharmacokinetic parameters were calculated using Phonenix WinNolin 8.0 software, and the bioequivalence of the test and the reference duloxetine hydrochloride was evaluated.
The main pharmacokinetic parameters of the test and the reference duloxetine hydrochloride in fasting test were as follows: Cmax were (16.70±5.94) and (16.70±7.10) ng·mL-1; AUC0-t were (217.28±98.82) and (222.42±117.98) ng·h·mL-1; AUC0-∞ were (225.91±100.35) and (229.40±119.34) ng·h·mL-1. The main pharmacokinetic parameters of the test and the reference duloxetine hydrochloride in fed test were as follows: Cmax were (20.10±9.56) and (21.30±10.90) ng·mL-1; AUC0-t were (266.99±146.66) and (273.22±168.09) ng·h·mL-1; AUC0-∞ were (277.83±154.73) and (283.51±174.63) ng·h·mL-1. The 90% confidence intervals of the main pharmacokinetic parameters of the test and reference preparations in fasting and fed tests were between 80.00%-125.00%.
The test and the reference duloxetine hydrochloride were bioequivalent under fasting and fed conditions.
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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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