Endometriosis
Conditions
Interventions
Group A:First cycle: Fasting single oral LY01021 80 mg (40 mg×2 capsules)
Cycle 2: Single oral LY01021 80 mg (40 mg×2 capsules) after a high-fat meal
Group B:First cycle: single oral LY01021 80 mg (40 mg×2 capsules) after a high-fat meal
Second Cycle: Single oral administration of LY01021 80 mg (40 mg×2 capsules) on an empty stomach
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily sign a written informed consent form; 2. Healthy female subjects aged 18-45 years (including cut-off values); 3. Body weight >=45.0kg, and body mass index (BMI) 19.0 kg/m^2<=BMI<=26.0 kg/m^2; 4. Female subjects of childbearing potential (not surgically sterilized and/or postmenopausal for less than 1 year, surgically sterilized as defined as having undergone hysterectomy or bilateral oophorectomy or tubal ligation) must have taken effective contraceptive measures (the use of hormonal-containing contraceptives is prohibited) within at least 2 weeks before screening, and the blood pregnancy test result is negative during the screening period; Female subjects of childbearing potential or their heterosexual partners agree to use effective contraceptive measures (the use of hormonal-containing contraceptives is prohibited) during the trial and within 3 months after the trial drug is used, or either party has been sterilized.
Exclusion criteria
Exclusion criteria: 1. Individuals who have previously suffered from any clinical serious diseases such as the blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental and metabolic abnormalities, or any other diseases or physiological conditions that can interfere with the test results; 1.Screening visits to vital signs, physical examinations, laboratory tests, and auxiliary examinations to identify abnormalities that the researcher determines will affect the study or pose significant risks to the subjects; 3. The recent delivery and miscarriage distance from the screening visit date is less than 6 months; 4. Screening for individuals who have experienced abnormal uterine bleeding within the first three months; 5. Individuals with a known history of allergies to any component or similar drug of the investigational drug, or individuals with allergies (previously allergic to two or more foods, drugs, or other items); 6. Subjects who cannot swallow the experimental drug or have gastrointestinal dysfunction determined by the researcher to affect drug absorption; 7. Individuals with a history of blood or needle fainting, or those who cannot tolerate venous puncture; 8. People with positive results of any test of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-AB), human immunodeficiency virus antibody (HIV Ab), and treponema pallidum specific antibody (TP); 9. The QT interval (QTc) corrected by the Fridericia formula during screening is greater than 470ms; 10. Use GnRH antagonists or any sex hormone small molecule drugs within the first month of screening; 11. Screening for individuals who have donated blood or lost a significant amount of blood ( >=200 mL, excluding menstrual bleeding in females) within the previous month, received blood transfusions or used blood products, underwent major surgical procedures, or planned to undergo surgical procedures during the study period; 12. Vaccination with live or attenuated vaccines within one month prior to screening or planned during or within one month after the study; 13. Participated in clinical trials within 3 months prior to administration and used any clinical trial drugs; Or use any prescription medication within 28 days prior to administration; Or use any over-the-counter medication, including health products, within 7 days before administration; 14. Consume foods or beverages rich in caffeine and/or purines (such as coffee, tea, chocolate, and carbonated beverages containing caffeine, cola, etc.), tobacco containing products (such as cigarettes, etc.), grapefruit and/or grapefruit juice, alcohol or alcoholic products within 48 hours before administration; 15. Pregnant or lactating women; 16. History of smoking and alcohol abuse within the first 3 months of screening: Smoking (more than 5 cigarettes per day or an equal amount of tobacco); Alcoholism (drinking more than 14 units of alcohol per week: 1 unit=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine), or not stopping the use of any alcoholic or tobacco products during the trial period, or a positive breath test for alcohol; 17. Drug abusers or those who have used soft drugs (such as marijuana) in the three months prior to screening, or those who have taken hard drugs (such as cocaine, phencyclidine, etc.) in the year prior to screening, or those who have obtained positive drug abuse screening results before admin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of LY01021 in plasma;PK parameters;To assess the relative bioavailability after meals compared to in the fasting state;Comparison of exposure parameters AUC0-t, AUC0-8, Cmax after prandial and fasting; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed