Assisted Reproduction
Conditions
Interventions
10mg group:Randomised in a 4:1 ratio to use trial drug and placebo
20mg group:Randomised in a 4:1 ratio to use trial drug and placebo
40mg group:Randomised in a 4:1 ratio to use trial drug and placebo
60mg group:Randomised in a 4:1 ratio to use trial drug and placebo
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
Female
Age
19 Years to 41 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily sign a written informed consent form; 2. Healthy premenopausal female participants aged 18-45 years (including boundary values); 3. Weight >= 45.0kg, and body mass index (BMI) 19.0 kg/m^2 <= BMI <= 26.0 kg/m^2; 4. Screen for regular menstrual cycles within the first 3 months (28 +/- 7 days); 5. The subjects must have taken effective contraceptive measures (hormone based contraceptives are prohibited) at least 2 weeks before screening, and the results of the blood pregnancy test during the screening period must be negative; The subjects or their opposite sex partners agree to take effective contraceptive measures (prohibiting the use of hormonal contraceptives) during the trial period and within 3 months after the trial medication, or either party has been sterilized.
Exclusion criteria
Exclusion criteria: 1. Individuals who have previously suffered from any clinically serious diseases such as blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders, metabolic disorders, or any other diseases or physiological conditions that can interfere with test results; 2. Screening visits for vital signs, physical examinations, laboratory tests, and auxiliary examinations that reveal abnormalities that the researcher determines may affect the study or pose significant risks to the subjects; 3. The distance between the nearest delivery and miscarriage screening visit is less than 6 months; 4. Screening for individuals who have experienced abnormal uterine bleeding within the previous 3 months; 5. Those who have a known history of allergies to any component or similar drug of the experimental drug, or those with an allergic constitution (those who have previously been allergic to two or more foods, drugs, or other substances); 6. Subjects who cannot swallow the investigational drug or have gastrointestinal dysfunction determined by the researcher to affect drug absorption; 7. Individuals with a history of dizziness or needle sickness, or those who cannot tolerate venipuncture; 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. During screening, female subjects had a blood follicle stimulating hormone (FSH) level of >= 35mIU/mL; 10. QT interval (QTc) corrected by Fridericia formula during screening is greater than 470ms; 11. Use GnRH agonists within 6 months prior to screening, or use GnRH antagonists or any sex hormone drugs within 2 months prior to screening; 12. Individuals who have donated blood or experienced significant blood loss (>= 200 mL, excluding menstrual bleeding in females), received blood transfusions or used blood products, undergone major surgical procedures, or plan to undergo surgical procedures during the study period within the past month prior to screening; 13. Vaccination with live or attenuated vaccines within one month prior to screening or planned during the study period or within one month after the study; 14. Participate in clinical trials and use any clinical trial drugs within 3 months before administration; Or use any prescription medication within 35 days prior to administration; Or use any over-the-counter medication, including health products, within 7 days prior to administration; 15. Within 48 hours before administration, consume foods or beverages rich in caffeine and/or purines (such as coffee, tea, chocolate, and carbonated drinks containing caffeine, cola, etc.), tobacco products (such as cigarettes, etc.), grapefruit and/or grapefruit juice, alcohol, or alcoholic products; 16. Pregnant or lactating women; 17. History of smoking and alcohol abuse within the past 3 months prior to screening: Smoking (more than 5 cigarettes per day or equivalent amount of tobacco); Alcoholism (drinking more than 14 units of alcohol per week: 1 unit=360 mL of beer or 45 mL of 40% spirits or 150 mL of wine), or being unable to stop using any alcoholic or tobacco products during the trial period, or having a positive breathalyzer test; 18. Drug abusers or those who have used soft drugs (such as marijuana) in the three months prior to screening, or those who hav
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs;Physical examination;laboratory test;Twelve-lead electrocardiogram;Adverse events;Tmax;Cmax;t1/2;CL/F;AUC0-t;Vd/F;ke;MRT;plasma FSH;plasma LH;plasma E2;plasma P; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed