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The intake of food could lead to various changes in the physiology of human gastrointestinal tract, such as the pH of the gastrointestinal, ionic strength, buffer capacity, the time of gastric emptying, visceral blood flow, and the metabolizing enzymes. These physiological changes would have effects on the release, absorption, distribution, metabolism, and/or excretion of a drug, leading to changes in its pharmacokinetics. Therefore, it is of great importance for clinical research and prediction of the food effect on novel drugs to understand the manner of change in the luminal condition of human gastrointestinal caused by food intake, as well as the manner of the effect on bioavailability. In this paper, we summarized the clinical trials about the food effect on drugs in clinical trial databases and literature first. Then, the guidelines relevant to clinical trials on food effect issued by the National Medical Products Administration (NMPA) of China, the United States FDA, and EMA were compared and summarized. Finally, taking the antitumor novel drugs as an example, we summarized and analyzed the clinical trials about food effect registered in China in the past 10 years, focusing on the main factors related to the food effect in the development of novel drugs, the official guidelines, as well as the current status of research in China, aiming to provide basic research data about the food effect for the development of novel drugs in China.
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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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