Primary objective: To evaluate the effect of rabeprazole on the primary pharmacokinetics of TQ05105 tablets. Secondary objective: To assess the safety and tolerability of single oral administration of TQ05105 tablets alone and in combination with rabeprazole in healthy study participants. To evaluate the effect of rabeprazole on the secondary PK parameters of TQ05105 and the pharmacokinetics of its active metabolite TQ12550.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
17
TQ05105 tablets are Janus kinase (JAK) inhibitors.
Rabeprazole sodium enteric-coated tablets.
The Third Xiangya Hospital, Central South University
Changsha, Hunan, China
Peak concentration (Cmax)
Maximum plasma drug concentration.
Time frame: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Area under the plasma concentration-time curve ( AUC0-t)
The area enclosed by the blood concentration curve to the timeline.
Time frame: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Maximum concentration (Tmax)
The time required to reach peak concentration after administration.
Time frame: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Plasma clearance (CL/F)
How much of the plasma is cleared per unit of time.
Time frame: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Plasma elimination half-life (t1/2)
The time it takes for the terminal phase blood concentration to drop by half.
Time frame: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Area under the plasma concentration-time curve ( AUC0-∞)
The area enclosed by the blood concentration curve to the timeline.
Time frame: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Adverse event rate
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The occurrence of all adverse events (AEs), and serious adverse events (SAEs).
Time frame: 14 days after the first dose
Hematology
Abnormal hematology
Time frame: 14 days after the first dose
Serum biochemistry
Abnormal serum biochemistry
Time frame: 14 days after the first dose
Coagulation
Abnormal coagulation
Time frame: 14 days after the first dose
Urinalysis
Abnormal urinalysis
Time frame: 14 days after the first dose
Blood pressure
Abnormal blood pressure
Time frame: 14 days after the first dose
Pulse
Abnormal pulse
Time frame: 14 days after the first dose
Respiration
Abnormal respiration
Time frame: 14 days after the first dose
Body temperature
Abnormal body temperature
Time frame: 14 days after the first dose
12-lead ECG
Abnormal 12-lead ECG
Time frame: 14 days after the first dose
Physical examination
Abnormal physical examination
Time frame: 14 days after the first dose
Symptoms
Abnormal symptoms
Time frame: 14 days after the first dose