Study Design
This study consisted of two parts. The first part was conducted under fasting conditions and the second part was conducted after the consumption of a high-fat meal. Both parts of the trial were single-dose, randomized, open, two-agent, four-cycle, fully replicated crossover trials. The study was conducted at the Phase I Clinical Research Center of Xiangya Hospital, Central South University. The order in which each subject received the test preparation or the reference preparation in the study was determined by a randomization table. The randomization table was generated by Guangzhou Jingyuan Pharmaceutical Research Co., Ltd. using SAS 9.4 statistical software in 1:1 groups. 48 subjects were randomly assigned to 2 dosing order groups in a 1:1 ratio. In the fasting trial, subjects were asked to fast for 10 hours at night and take the drug in the fasted state; in the postprandial trial, subjects were to eat a high-fat meal 30 min before drug administration and finish it within 30 min, taking the drug at 30 min ± 1 min from the start of the meal. Subjects were to cross-dose the drug in the specified order (Group A: subject preparation - reference preparation - subject preparation - reference preparation; Group B: reference preparation - subject preparation - reference preparation - subject preparation). One dose of the corresponding test preparation or reference preparation was administered once per cycle with 240 mL of warm water, with a washout period of 7 days per cycle. All subjects were admitted to the Phase I clinical study center one day before dosing and underwent admission health status assessment, vital sign measurements, urine addiction drug screening, alcohol breath test, and blood pregnancy test (women of childbearing age only). Vital signs such as temperature, pulse, and sitting blood pressure were measured within 1 h before and at different times including (2, 4, 8, 24, 48, and 72 h) after dosing.