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To evaluate the safety and bioequivalence of two formulations of agomelatine tablets in healthy Chinese subjects.
A randomized, open-label, two-treatment, four-period, two-sequence, fully replicated crossover bioequivalence study was conducted under both fasting and fed conditions. Each subject received a single 25 mg dose of the test (T) product or reference (R) product agomelatine tablet in both fasting and fed conditions. Plasma concentration of agomelatine was determined by the liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The main pharmacokinetic parameters were derived using WinNonlin 8.3 software.
A total of 128 subjects were enrolled, 64 in the fasting group and 64 in the fed group. The primary pharmacokinetic(PK) parameters of the test and reference formulations under fasting condition were as follows: Cmax were (25.55±29.65) and (26.59±28.04) ng·mL-1, AUC0-t were (28.59±26.66) and (29.33±26.98) ng·h·mL-1, AUC0-∞ were (29.13±26.96) and (29.62±27.17) ng·h·mL-1. The primary pharmacokinetic parameters of the test and reference formulations under fed condition were as follows: Cmax were (26.26±23.29) and (28.97±34.82) ng·mL-1, AUC0-t were (35.75±27.67) and (36.91±32.59) ng·h·mL-1, AUC0-∞ were (36.15±27.89) and (37.14±32.69) ng·h·mL-1. Under both fasting and post-meal conditions, the 90% confidence interval of the geometric mean ratio (GMR) of the main PK parameters of the test formulation of agomelatine tablets compared to the reference formulation fell within the range of 80%-125%.
The test formulations and reference formulations of agomelatine are bioequivalent under both 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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