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To evaluate the bioequivalence of montelukast sodium chewable tablets test formulation and reference formulation in Chinese healthy subjects.
A single-center, single-dose, two-period, randomized, open-label, self-cross-over design was designed. A single oral dose of montelukast sodium chewable tablets 5 mg was administered under fasting or fed conditions in each period. The blood concentration of montelukast in plasma was determined by liquid chromatography-mass spectrometry, and pharmacokinetic parameters were calculated by SAS 9.4 software.
Twenty-six and 30 cases healthy subjects were included in the fasting and fed groups, respectively. The main pharmacokinetics (PK) parameters of the test formulation and reference formulation in the fasting group: Cmax were (331.00±86.00) and (327.08±76.03) ng·mL-1; AUC0-t were (2 265.12±560.34) and (2 318.56±589.51) ng·mL-1·h; AUC0-∞ were (2 352.60±591.43) and (2 409.12±636.79) ng·mL-1·h, respectively. The main PK parameters of the test formulation and reference formulation in the fed group: Cmax were (262.07±52.94) and (256.73±63.07) ng·mL-1; AUC0-t were (2 014.43±356.47) and (2 071.53±462.56) ng·mL-1·h; AUC0-∞ were (2 072.30±384.30) and (2 138.57±509.46) ng·mL-1·h, respectively. The 90% confidence intervals of the geometric mean ratios of the main PK parameters of montelukast in the test formulation and reference formulation in fasting and fed groups were all within 80.00%-125.00%. In the fasting test, a total of 8 cases (32.00%) subjects had 11 adverse reactions, and in the fed test, a total of 11 cases (36.67%) subjects had 18 adverse reactions.
The test and reference montelukast sodium chewable tablets were bioequivalent under 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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