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be withdrawn 0.5-1.0mL in advance.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.