FE
This study was designed as a single-center, randomized, open-label, two-cycle, two-crossover, single-dose food effect study to evaluate the effects of a high-fat diet on the PK and safety of AD16 tablets in healthy adults. Assessing the effects of food on drug bioavailability is important to ensure the safety and efficacy of drugs for clinical use. The study evaluated the situation and degree of drug exposure in the body by comparing PK parameters under the conditions of fasting and eating a high-fat diet, so as to evaluate whether food has an influence on AD16. A total of 16 subjects were randomly divided into two equal groups: A and B. According to the group, the subjects received a single dose of AD16 at cycles 1 and 2 under fasted state or after consuming a standardized high-fat meal comprising a total calorie count of 916, including 168, 499, and 249 cal of proteins, fats, and carbohydrates, respectively.