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Outline
To evaluate the bioequivalence of reference and test formulations of glucosamine sulfate capsules after single dose in healthy Chinese volunteers under fasting condition.
A total of 30 healthy human volunteers participated in a randomized, open, single-dose, three-cycle, partial repeated, three-crossover study. Volunteers were given single dose (0.25 g) of tested and reference formulations of glucosamine sulfate capsules under fasting state. Plasma concentration of glucosamine after administration was analyzed by LC-MS/MS method. Non-compartmental pharmacokinetics parameters were calculated by WinNonlin 6.3, and bioequivalence was evaluated using reference-scaled average bioequivalence (RSABE) method by SAS 7.1.
For test and reference formulations, Cmax of glucamine (after baseline correction) were (585.0±282.2) and (641.0±293.6) ng·mL-1, Tmax were 1.5 (0.5, 5.0) and 1.5 (0.5, 5.0) h, t1/2 were (1.8±1.4) and (1.5±0.5) h, AUC0~t were (2 089.2±749.5) and (2 298.2±928.4), AUC0~∞ were (2 095.3±749.7) and (2 303.1±929.0), respectively. The geometric mean ratios (GMR) of AUC0~t, AUC0~∞ and Cmax between test and reference formulations were both within 90% confidence interval broadened bioequivalent rage 74.9% to 133.6% and 70.1% to 142.7%, and regular bioequivalent range (80% to 125%).
Two formulations were equivalent under fasting condition.
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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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