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.
Signed informed consent prior to the study, fully understood the study content, procedures and potential adverse reactions; able to complete the study per protocol requirements.
The participant (including partner) agrees not to plan pregnancy, sperm donation or egg donation from screening until 6 months after the last study drug administration, and is willing to use effective contraception.
Healthy male and female participants aged 18-45 years (inclusive).
Male body weight ≥ 50.0 kg; female body weight ≥ 45.0 kg.BMI = weight (kg)/height² (m²), range 18.0-28.0 kg/m² (inclusive).
Participants with clinically significant abnormalities in vital signs, physical examination, ECG or clinical laboratory tests, and deemed unsuitable for participation by the investigator.
Participants with severe or chronic diseases of the circulatory, digestive, respiratory, urinary, nervous, hematologic, endocrine/metabolic, neoplastic, immune or psychiatric systems within the past 1 year or currently, or any other disease that may interfere with study results.
Platelet count or absolute neutrophil count below the lower limit of the reference range at screening.
Any disease increasing bleeding risk, such as hemorrhoids, acute gastritis, gastric or duodenal ulcer.
Sequential
TQ05105 tablets
DrugTQ05105 tablets are Janus kinase (JAK) inhibitors.
Rabeprazole sodium enteric-coated tablets
DrugRabeprazole sodium enteric-coated tablets.
Peak concentration (Cmax)
Maximum plasma drug concentration.
Area under the plasma concentration-time curve ( AUC0-t)
The area enclosed by the blood concentration curve to the timeline.
Maximum concentration (Tmax)
The time required to reach peak concentration after administration.
Plasma clearance (CL/F)
How much of the plasma is cleared per unit of time.
Plasma elimination half-life (t1/2)
The time it takes for the terminal phase blood concentration to drop by half.
Area under the plasma concentration-time curve ( AUC0-∞)
The area enclosed by the blood concentration curve to the timeline.
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