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To study the pharmacokinetics of atomoxetine hydrochloride and to evaluate the bioequivalence of domestic generic and reference atomoxetine hydrochloride (25 mg) in healthy Chinese volunteers.
A randomized, open, two-period crossover study with a 7-day washout period was conducted under fasting and fed conditions in healthy Chinese volunteers (24 subjects/condition). Eligible subjects randomly received a 25 mg single dose of either the test or the reference formulation. A serial blood samples were collected over a 36-hour interval following the administration. The concentration of atomoxetine in plasma was determined by validated HPLC-MS/MS method. Noncompartmental model was applied for pharmacokinetic analysis. The geometric mean ratios (GMRs) and the corresponding 90% confidence intervals of Cmax, AUC0-t and AUC0-∞ were acquired for bioequivalence analysis.
The pharmacokinetic parameters of the test and reference capsules under fasting condition are as follows: Cmax are (282.13±91.45) and (271.42±79.44) ng·mL-1; AUC0-t are (2 009.91±1 258.81) and (1 942.78±1 198.58) ng·h·mL-1, AUC0-∞ are (2 051.51±1 306.58) and (1 982.65±1 242.27) ng·h·mL-1. The pharmacokinetic parameters of the test and reference capsules under fed condition are as follows: Cmax are (189.26±77.24) and (185.80±63.09) ng·mL-1; AUC0-t are (1 804.43±1 107.08) and (1 740.68±1 003.93) ng·h·mL-1, AUC0-∞ are (1 847.90±1 164.11) and (1 779.44±1 053.44) ng·h·mL-1. The 90% confidential intervals of the GMRs of Cmax, AUC0-t and AUC0-∞ fell within the bioequivalence criteria (80.00%~125.00%). No serious adverse event was observed.
The domestic atomoxetine hydrochloride was bioequivalence to the reference formulation. Both formulations were generally well tolerated.
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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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