Study to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the Pharmacokinetics of TQ05105 Tablets

Inclusion criteria

• 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).

Exclusion criteria

• 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.
• Alanine aminotransferase (ALT) > 1.2×ULN, aspartate aminotransferase (AST) > 1.2×ULN, alkaline phosphatase (ALP) > 1.2×ULN, total bilirubin (TBIL) > 1.2×ULN, or any clinically significant abnormality judged by the investigator.
• Any malignancy within the past 5 years.
• Any condition that may affect absorption, distribution, metabolism or excretion of study drug (e.g., inability to swallow), or history of gastrointestinal resection that may affect drug disposition.
• Allergy to rabeprazole, TQ05105 or their excipients; or history of multiple allergies (≥2 substances), including drug allergy, and tendency to develop rash, eczema, urticaria, asthma, etc.
• Use of any strong or moderate inducers or inhibitors of CYP3A4, CYP2C9 and CYP2C19 within 4 weeks prior to screening.
• Use of any prescription drugs, over the counter medications, herbal medicines or dietary supplements (e.g., vitamins, calcium supplements) within 4 weeks prior to screening.
• Use of any acid suppressive therapy within 3 months prior to screening.
• Participation in any clinical trial involving investigational drugs within 3 months prior to screening or within 5 half lives of the study drug (whichever is longer).
• Positive results for HIV antibody, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV) or syphilis antibody.
• Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m² at screening.
• Average daily cigarette consumption >5 cigarettes within 3 months prior to screening.
• History of drug abuse within 3 months prior to screening, or positive urine drug screen.
• Regular alcohol consumption within 3 months prior to screening (≥14 units/week; 1 unit = 360 mL beer / 45 mL 40% spirits / 150 mL wine), or positive alcohol breath test.
• Blood donation or blood loss ≥200 mL, or plasma exchange within 4 weeks prior to screening.
• Consumption of alcohol (or positive alcohol breath test), grapefruit juice, coffee, tea, cola, chocolate or related food/beverage within 72 hours before dosing.
• Pregnant or breastfeeding female participants, positive serum pregnancy test, or unprotected sexual intercourse within 2 weeks prior to screening for women of childbearing potential.
• Strenuous exercise (e.g., marathon, weightlifting) within 2 weeks prior to screening.
• Any other condition deemed unsuitable for participation by the investigator.