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To study the bioequivalence of two formulations of haloperidol tablets in healthy Chinese subjects.
The randomized, open, single dose, two periods, crossover study design was adopted in the study. Twenty-eight healthy subjects were enrolled under fasting condition and given either test preparation or reference preparation 2 mg respectively in one period. After collecting plasma samples, the plasma concentrations of haloperidol were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The pharmacokinetic parameters were calculated by WinNonlin 8.0 and the bioequivalence was evaluated using the average bioequivalence (ABE) method.
The pharmacokinetic parameters of haloperidol of the test preparation or reference preparation were as follow: Cmax were (719.50±378.43) and (703.43±329.63) pg·mL-1, AUC0-t were (1.94×104±6 766.21) and (1.94×104±6 522.79) pg·h·mL-1, AUC0-∞ were (2.31×104±7 693.66) and (2.30×104±7 309.97) pg·h·mL-1. The 90% confidence intervals (CI) of the geometric mean ratio (GMR) were 92.46%-114.76%, 96.70%-108.15%, 96.36%-111.34% for Cmax, AUC0-t and AUC0-∞, respectively, which were within the acceptance criteria of 80.00%-125.00%.
The two preparations of haloperidol tablets were bioequivalent in Chinese healthy 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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