Pharmacokinetic Effect of Y-3 on Repaglinide，Warfarin and Omeprazole in Healthy Participants

Launched by NEURODAWN PHARMACEUTICAL CO., LTD. · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a new injection called Y-3 affects the way the body handles three common medicines: repaglinide (used for blood sugar control), warfarin (a blood thinner), and omeprazole (used for stomach acid). The main goal is to see if taking Y-3 changes how these medicines work in healthy adults, and whether it causes any interactions or safety concerns when used together. This information will help doctors understand if Y-3 can be safely used alongside these medicines once it’s approved.

To join this study, participants need to be healthy adults between 18 and 50 years old, with a normal weight and overall good health based on medical tests. They must understand the study and agree to follow its rules, such as eating only certain foods, avoiding alcohol, smoking, and other medicines during the study, and using non-drug birth control if applicable. Participants will take the three medicines first by themselves, then again while receiving the Y-3 injection, and will have blood tests to check how the medicines are processed in their bodies. The study lasts about four nights at a research center, and participants will be closely monitored to ensure their safety throughout.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1) Participants fully understand the purpose, nature, methods and possible adverse reactions of the trial, voluntarily act as participants, and sign the informed consent form before the start of any study procedures; 2) Healthy male or female participants aged 18 \~ 50 years old (including 18 and 50 years old); 3) Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, body mass index \[BMI = weight (kg)/ height (m)2\]: 19.0-26.0 kg/m2, including 19.0 and 26.0 kg/m2; 4) The results of vital signs, physical examination, 12-lead electrocardiogram examination, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, kidney), chest X-ray and laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, four items before blood transfusion, fecal occult blood examination) are normal or judged by the investigator to be abnormal of no clinical significance; 5) Participants (including male participants) have no fertility plan and voluntarily take effective contraceptive measures (contraceptive measures other than contraceptive drugs during the trial) within 3 months after signing the informed consent form to dosing, and have no sperm donation and egg donation plans; 6) Able to communicate well with the investigator, and understand and comply with the requirements of the trial.
• Exclusion Criteria:
• • 1) People with allergies: allergies to medicines, food, pollen, etc., or those who have a history of allergy to repaglinide tablets, warfarin sodium tablets, omeprazole enteric-coated capsules, Y-3 for injection or any of components of above investigational products; 2) Those who have diseases or medical history that may affect drug absorption, distribution, metabolism, excretion or interpretation of safety data, or diseases or medical history that can reduce compliance, including but not limited to gastrointestinal, renal, hepatic, pulmonary, neurological, hematological, endocrine, tumor, immunologic, psychiatric or cardiovascular and cerebrovascular diseases (especially liver and kidney insufficiency, diabetes, hypoglycemia, bleeding tendency or cachexia, malignant hypertension, thrombocytopenia); 3) Those who have undergone surgery within 6 months before the first use of the investigational products, or have undergone surgery that will affect the absorption, distribution, metabolism, and excretion of the investigational products, or plan to undergo surgery during the trial; 4) Those who have a history of fainting needle and blood sickness, cannot tolerate venipuncture blood collection, cannot tolerate intravenous administration and/or have difficulty in blood collection; 5) Those who cannot comply with the uniform diet (such as special dietary requirements, intolerance to standard meals, etc.); 6) For patients with creatinine clearance \<80 mL/min, creatinine clearance (mL/min) = \[(140-age) × body weight (kg)\]/\[72×Scr(mg/dl)\] or creatinine clearance (mL/min) = \[(140-age) × body weight(kg)\]/\[0.818×Scr(μmol/L)\], female study participants were × 0.85 according to the calculated results; 7) Those who have participated in or are participating in other clinical trials within 3 months before the first use of the investigational products (drug clinical trial is defined as the use of clinical investigational products), or plan to participate in other clinical trials during the trial period or within 1 month after the end of the trial, or those who do not come to participate in clinical trials in person; 8) Those who have donated blood (including component blood) or had heavy bleeding (greater than 400 ml, except for blood loss during normal menstrual period in women) within 3 months before the first use of the investigational products, or received blood transfusion or used blood products, or plan to donate blood or blood components during the study or within 1 month after the end of the study; 9) Those who have had significant changes in diet or exercise habits within 3 months before the first use of the investigational products; 10) Those who have an average daily smoking volume of more than 5 cigarettes within 3 months before the first use of the investigational products, or cannot stop using any tobacco products (including any smoking cessation products containing nicotine) within 48 hours before the first use of the investigational products and during the trial; 11) Those who have a history of drug abuse or drug use within 6 months before the first use of the investigational products, or who are positive for drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinolic acid, dimethylenedioxyamphetamine); 12) Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) per week within 3 months before the first use of the investigational products, or who cannot abstain from alcohol or stop using any diet containing alcohol within 48 hours before the first use of the investigational products and during the trial, or have a positive alcohol breath test result (greater than 0.0 mg/100 mL); 13) Those who consume excessive amounts of tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months before the first use of the investigational products, or cannot stop using caffeine-rich foods or beverages (such as chocolate, coffee, tea, cola, etc.) within 48 hours before the first use of the investigational products and during the trial; 14) Those who have used any drug that can change the activity of liver drug enzymes within 1 month before the first use of the investigational products; 15) Those who have been vaccinated within 1 month before the first use of the investigational products, or plan to receive any vaccine during the trial or within one week after the end of the trial; 16) Those who have used any prescription medicines, over-the-counter medicines, Chinese herbal medicines, health products and functional vitamins within 14 days before the first use of the investigational products; 17) Those who have one or more positive test results for hepatitis B surface antigen, hepatitis C virus antibody, HIV1/2 antigen/antibody and treponema pallidum antibody; 18) Females of childbearing potential who have had unprotected sex within 14 days prior to the first use of investigational products, or females who are pregnant or lactating, or who have a positive pregnancy test result; 19) Those who cannot stop ingesting grapefruit, dragon fruit, mango, lime, star fruit and other fruits or related products that affect metabolic enzymes within 48 hours before the first use of the investigational products and during the test; 20) Other conditions judged by the investigator to be inappropriate for enrollment.