Breast cancer, prostate cancer
Conditions
Interventions
T-R:In the first period (Day 1), subjects received a single intramuscular injection in the buttock of 3.6 mg of the test formulation LY01005.In the second period (Day 65), subjects received a single i
R-T:In Period 1 (Day 1), a single 3.6 mg dose of the reference formulation LY01005 was administered via intramuscular injection in the buttock.In Period 2 (Day 65), a single 3.6 mg dose of the test fo
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
Female
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to sign the informed consent form and be able to follow the trial protocol and visit schedule; 2. Female, aged between 40 and 65 (inclusive); 3. Healthy postmenopausal women, i.e., those who have experienced spontaneous amenorrhea for 12 months or longer (without any other causes of amenorrhea) and have a follicle-stimulating hormone (FSH) level greater than 40 mIU/mL (excluding amenorrhea caused by surgery or breastfeeding); 4. Body Mass Index (BMI) is within the range of 18.5~28.0 kg/m^2 (including the critical value), and the body weight is >=45.0 kg; 5. The pregnancy test result is negative during screening. The subject and their spouse/partner agree not to plan for pregnancy (including egg donation) during the entire study period and for at least 3 months after the last dose of medication, and voluntarily adopt effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Individuals who have previously or currently suffered from any clinically severe diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry, or metabolic abnormalities, or any other diseases that may interfere with the test results; 2. History of allergy to drugs, food, or other substances; 3. Those who have undergone surgical operations within the first 4 weeks before the trial, or plan to undergo surgical operations during the study period; 4. Those who have taken any medication or health supplements (including Chinese herbal medicine) within 14 days before the test; 5. Those who have used any drugs that inhibit or induce liver metabolism of drugs within 30 days before the test (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 6. Those who participated in any clinical trial and took any clinical trial drug within 3 months before the trial; 7. Those who have donated blood or suffered significant blood loss (>=200 mL, excluding blood loss during menstruation in females), received blood transfusions, or used blood products within the previous 3 months prior to enrollment; 8. Pregnant or lactating women, as well as those who cannot adopt one or more non-pharmacological contraceptive measures during the trial period; 9. Those who have special dietary requirements and cannot adhere to a uniform diet; 10. Those who consume excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups, with 1 cup = 250 mL) daily; 11. Smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to the trial, or those who cannot stop using any tobacco products during the trial period; 12. Individuals who are alcoholics or have regularly consumed alcohol within the previous 6 months prior to the trial, meaning consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirit or 150 mL of wine), or who are unable to discontinue the use of any alcoholic products during the trial period; 13. Individuals who abuse drugs or have used soft drugs (such as marijuana) within 3 months prior to the trial, or have taken hard drugs (such as cocaine, phencyclidine, etc.) within 1 year prior to the trial; 14. Patients with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or clinically significant abnormalities in physical examination, electrocardiogram, and laboratory tests (subject to the judgment of the clinical research doctor); 15. Those who may not be able to complete this study due to other reasons or who are deemed ineligible by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (plasma concentration of goserelin); | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-lead electrocardiogram;vital signs; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed