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.