A Drug-Drug Interaction Study Between HS-10374 Tablets and Drospirenone and Ethinyl Estradiol Tablets(Yasmin®)

Korábbi kezelés

• Severe pre-existing or current diseases affecting the nervous, psychiatric, digestive, circulatory, respiratory, urinary, cardiovascular, or immune systems-or any newly diagnosed condition prior to dosing-deemed by the investigator to contraindicate participation; including history of gastrointestinal disorders (e.g., gastric ulcer, reflux esophagitis).
• Current or previous history of: Venous thromboembolism (e.g., deep vein thrombosis, pulmonary embolism), Cerebrovascular disorders, Coronary artery disease, hypertension, Thrombogenic cardiac valvulopathy or rhythm disorders (e.g., subacute bacterial endocarditis with valvular disease, atrial fibrillation), Hereditary/acquired hypercoagulable states (e.g., Factor V Leiden mutation family history), Diabetes with vascular complications, Headaches with focal neurological symptoms, Migraine (with or without aura), Cholestatic jaundice and/or pruritus during prior hormone therapy.
• Current or previous renal impairment or adrenal insufficiency.
• Current or previous estrogen/progestin-sensitive cancers (e.g., breast cancer).
• Severe infections ≤30 days before screening (e.g., cellulitis, pneumonia, sepsis) OR herpes zoster within 3 months prior.
• Participants who have undergone surgery affecting drug absorption, distribution, metabolism, or excretion, deemed ineligible by the investigator.
• Individuals with a history of hypersensitivity or allergic predisposition (e.g., to pollen, ≥2 drugs/foods), or known allergy to: Active ingredients/excipients of the investigational products (Drospirenone and Ethinylestradiol Tablets \& HS-10374 Tablets), Other Janus Kinase (JAK) inhibitors.
• Participation in any other clinical trial involving investigational drugs/devices within 3 months prior to screening .
• Blood donation or significant blood loss (>400 mL) within 3 months before screening, or plans to donate blood during the trial or within 1 month after completion .
• Ingestion of grapefruit or grapefruit products within 48 hours before the first dose of investigational products .
• Excessive consumption of tea, coffee, or caffeine-containing beverages (>8 cups/day on average; 1 cup=200 mL) within 3 months prior to screening .
• Participants who smoked ≥1 cigarette/day within 3 months before screening, were unable to quit tobacco products during the trial, or tested positive for nicotine.
• Participants who drank alcohol frequently (>14 units/week, 1 unit =14 g alcohol) within 3 months before screening, couldn't stop using alcohol during the trial, or tested positive for alcohol in breath tests.
• Participants who used alcohol-containing products within 24 h before taking the test drug or had a positive alcohol breath test result.
• Participants who used drugs affecting liver metabolic enzymes (CYP3A, CYP1A2, CYP2D6, CYP2B6) or P-gp/BCRP activity, HIV/HCV protease inhibitors, non-nucleoside reverse transcriptase inhibitors, or hormonal drugs within 30 days before the first test drug dose.
• Participants who used long-acting estrogen/progestin injectables or implants within 12 months before the first dose, or transdermal contraceptives or intrauterine devices with hormones within 3 months before enrollment.
• Participants who used drugs altering gastric pH (e.g., rebamipide, omeprazole, lansoprazole, ranitidine, aluminum hydroxide) within 30 days before screening.
• Participants who used prescription drugs, OTC drugs, herbs, or health products (excluding local-acting topical agents) within 14 days before screening.
• Participants who used vaccines within 14 days before screening or planned to use them during or within two weeks after the trial.
• Participants who had unprotected sex within 14 days before screening.

Más betegség

• Positive results for any of the following during screening: Hepatitis B surface antigen (HBsAg), hepatitis C antibody, HIV antibody/p24 antigen, or Treponema pallidum antibody.
• History of myopathy or rhabdomyolysis.
• History of tuberculosis (TB).
• Undiagnosed abnormal uterine/vaginal bleeding.
• Benign/malignant liver tumors or severe liver disease with safety risks per investigator judgment.
• Active/latent TB infection during screening, assessed by: T-SPOT.TB (interferon-gamma release assay),Chest X-ray. Exclusion if: Chest X-ray shows TB lesions OR T-SPOT.TB positive.
• Participants with a history of drug abuse, dependence, or illicit drug use within 5 years before screening, or tested positive for drug abuse in urine tests.
• Participants unable to tolerate venipuncture/indwelling needle blood collection or with a history of fainting at the sight of blood.

Laborértékek

• Participants with clinically significant abnormalities in physical examination, vital signs, ECG, clinical laboratory tests, abdominal ultrasound, gynecological color ultrasound, or breast color Doppler ultrasound, as judged by the investigator.
• Screening values exceeding 1.5×ULN for ALT, AST, or creatine kinase (CK), with clinical significance per investigator assessment.
• Screening serum creatinine >1×ULN, judged clinically significant by the investigator.
• QT interval prolongation on 12-lead ECG during screening (QTcF ≥470 ms).

Egyéb

• Participants who tested positive for pregnancy or were breastfeeding at screening.
• Participants unlikely to complete the trial for other reasons or deemed unsuitable by the investigator.

• Participants who sign the informed consent form before the trial, fully understand the trial content, procedures, and potential adverse reactions, and voluntarily commit to complying with all trial requirements.
• Healthy female participants aged 18 to 40 years (inclusive), with age calculated based on the date of signing the informed consent.
• Participants weighing ≥45 kg, with a body mass index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive). BMI = weight (kg) / height² (m²).
• Participants who agree to abstain from conception/donation of oocytes and practice complete abstinence from signing the informed consent until 40 days after the last dose.