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To analyze the pharmacokinetics of bicalutamide (50 mg) in healthy Chinese male volunteers and to evaluate the bioequivalence of domestic generic and reference bicalutamide (CASODEX®) in healthy Chinese male volunteers.
A randomized, open, two-cycle, two-sequence, and cross-over study with a 56-day washout period was conducted under fasting and postprandial conditions in healthy Chinese male volunteers (40 subjects/condition). Eligible subjects randomly received a single 50 mg dose of either the test or the reference formulation. A serial blood samples were collected over a 576-hour interval following drug administration. The concentrations of bicalutamide in EDTA-K2 human plasma were determined by the liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, with non-compartmental model used for pharmacokinetic analysis. The bioequivalence of the two preparations was determined according to whether the 90% confidence interval (CI) of Cmax, AUC0-t and AUC0-∞ geometric mean ratio was within the range of 80.00%~125.00%.
The pharmacokinetic parameters of the test and reference capsules under fasting condition are as follows: Cmax (1 030±196) and (898±167) ng·mL-1; AUC0-t (224 000±42 900) and (196 000±48 400) h·ng·mL-1, AUC0-∞ (243 000±56 900) and (212 000±60 100) h·ng·mL-1. The pharmacokinetic parameters of the test and reference capsules under fed condition are as follows: Cmax (1 260±164) and (1 210±153) ng·mL-1; AUC0-t (245 000±40 700) and (241 000±44 700) h·ng·mL-1; AUC0-∞ (266 000±55 700) and (259 000±57 000) h·ng·mL-1. The 90% confidential intervals of the GMRs of Cmax, AUC0-t and AUC0-∞ fall within bioequivalence criteria (80.00%~125.00%). No serious adverse event was observed.
The domestic bicalutamide formulation is bioequivalent to the reference formulation CASODEX®. Both formulations are 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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