2.2 Assessments
2.2.1 PK
Approximately 4mL of blood was collected into heparin lithium anticoagulant tubes, if the indwelling needle was used, the blood should be withdrawn 0.5-1.0mL in advance. The blood samples should be centrifuged at room temperature for 10 mins (2500 g) for no more than one hour, the plasma samples were collected and stored at -70℃ (10℃) for long-stem storage or stored at -20℃ for no more than 12 hours.
The concentration of SHR2554 in plasma samples was determined by the Shanghai Institute of Pharmacy, Chinese Academy of Sciences (Shanghai), and the analytical method has been verified. High-performance liquid chromatography-tandem mass spectrometry was been used for the concentration of plasma samples. The plasma samples were stored at -70℃, and should be detected within 176 days. The concentration range of the calibration standard curve was 1.00–500 ng/mL; the regression equation showed linear fitting, and the weight coefficient was W= 1/X2. The lower limit of quantification (LLOQ) of SHR2554 was 1.00ng/mL. All concentration which was lower than LLOQ was referred to as blow the detection limit.
2.2.2 Safety
All adverse events (AEs) were recorded from the time of the first dose of SHR2554 until the end of the follow-up whether they were related to investigation drugs or not. Due to the pigment group of rifampicin metabolites, subjects whose urine, stool, saliva, sputum, or tears appeared orange-red after taking rifampin were not recorded as AEs. All subjects were received the physical examination on day-0 and day 13. All account of physical examination was provided in supplementary.