Bioequivalence
Conditions
Interventions
Single dose group:Twenty-four healthy men and 24 deregulated healthy women were randomly divided into two groups, 24 in each group (12 males and 12 females) and given test preparations (high-purity ur
Multiple dose groups:After down-regulation, 48 healthy female subjects were randomly divided into two groups, 24 in each group. The test preparations were given (high-purity urinary insulin for inject
Pre-test:Four healthy men and four deregulated healthy female subjects were randomly divided into two groups of 4 (2 males and 2 females) and given test preparations (high-purity urinary insulin for i
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Female subject: 1. Healthy female subjects who voluntarily signed informed consent; 2. Persons with potential fertility. When signing the informed consent document, subjects must be at least 20 years old (including the 20th birthday) and not more than 39 years old (1 day before the 40th birthday); 3. Body mass index of 19 to 28 kg/m2 (including the boundary value); 4. 21 to 35 days of regular menstrual cycle (including the boundary value); 5. history of sexual life; 6. Subjects who voluntarily receive down regulation and meet the down regulation criteria; 7. agree to use the following contraceptive methods for contraception between signing the ICF three months after completion of the test (for all subjects assigned to the group): (1) Intrauterine device; (2) Use a condom or isolation cap (septum or cervix/cap) for barrier contraception; (3) Avoid sexual activity; 8. Lower stable FSH and LH levels. Serum FSH = 5 IU/L, LH = 5 IU/L and estradiol = 50 pg/mL when measured on day -1; 9. Negative microbiological examination at screening. Includes Human Immunodeficiency Virus Antibody (HIV-AB), Hepatitis B Surface Antigen (HBs-AG), Hepatitis C Virus Antibody (HCV-AB), Treponema pallidum; 10. Follow Medical History, Physical Examination, Chest Radiography, 12-lead ECG, blood pressure, pulse, and blood and urine laboratory test results, the subject's health; 11. Screening and day-1 urine drug screening was negative; 12. Screening and day-1 Alcohol test (exhale) negative; 13. Negative nicotine screening period. Male subject: 1. Healthy male subjects who voluntarily signed informed consent; 2. Subjects must be at least 20 years old (including the 20th birthday) and not more than 39 years old (1 day before the 40th birthday) when signing the informed consent document; 3. The body mass index is 19-28 kg/m2 (including the boundary value); 4. Agree to use the following methods of contraception for contraception between signing the ICF three months after completing the test (for all subjects assigned to the group): (1) Barrier contraception using a penis sheath or isolation cap (septum or cervix/cap); (2) Male sterilization (recorded evidence of absence of sperm in ejaculate semen); (3) Avoidance of sexual activity; 5. FSH = 5 IU/L, LH = 5 IU/L; 6. Negative microbiological examination at screening. Including human immunodeficiency virus antibody (HIV-AB), hepatitis B surface antigen (HBs-AG), hepatitis C virus antibody (HCV-AB), treponema pallidum infection; 7. According to medical history, physical examination, chest Tablets, 12-lead ECG, blood pressure, pulse and blood and urine laboratory test results, the subject's health; 8. Screening and day-1 urine drug screening was negative; 9. Screening and -1 Day alcohol test (expiratory) negative; 10. Screening nicotine negative.
Exclusion criteria
Exclusion criteria: Female subject: 1) A clinically significant disease or illness with kidney, liver, gastrointestinal, cardiovascular or musculoskeletal system History, or clinically significant history of psychosis, immunity, endocrine or metabolic disease; 2) Previous or current endocrine abnormalities such as: hyperprolactinemia, polycystic ovary syndrome, ovarian dysfunction, thyroid dysfunction, adrenal glands Functional abnormalities, etc.; 3) History of ovarian surgery; 4) Clinically significant findings of vaginal ultrasound, cervical cytology, or gynaecological examination at the time of screening or Day -1, including any ovarian cysts or ovaries (after administration of Superb? At any time point, any subject with ovarian cysts >15 mm in diameter will no longer be eligible for enrollment; 5) Have any malignancy (including a history of malignancy); 6) Have participated within 3 months of screening Clinical studies of other drugs or devices; 7) Use of any FSH formulation or urinary gonadotropin (hMG) preparation within the first 3 months of screening; 8) Blood donation within 3 months before study, or blood loss = 500 ml; 9) Known to be allergic to any component of the study drug (main components: FSH, LH; Excipients: lactose, polysorbate 20. Sodium dihydrogen phosphate, disodium hydrogen phosphate, etc.); 10) Contraindications for the use of high-purity urinary gonadotropins (including: ovarian enlargement or cysts caused by non-polycystic ovary syndrome; unexplained gynecological bleeding; uterus, Ovarian or mammary tumors); 11) Contraindications with deregulating drugs (known to be allergic to tramadol, osteoporosis); 12) Taking down regulation in addition to the protocol within 4 weeks before the first dose of study drug Any drug other than drugs; 13) Pregnancy or breastfeeding women; 14) Subjects with a fertility plan within half a year; 15) For any reason, the process specified in the research protocol cannot be complied with, including planned visits and Laboratory tests; 16) Any other factors that the investigator considers inappropriate for the subject to enter the trial. Male subject: 1) A clinically significant disease or illness with kidney, liver, gastrointestinal, cardiovascular or musculoskeletal system. History, or history of clinically significant mental illness, immunity, endocrine or metabolic disease; 2) Previous or current endocrine abnormalities (eg abnormal thyroid function, abnormal adrenal function, etc.); 3) Any malignancy (including malignancy) Medical History); 4) Clinical studies of other drugs or devices taken within 3 months prior to screening; 5) Use of any FSH or urinary gonadotropin (hMG) preparations within 3 months prior to screening; 6) Top 3 studies Blood donation within month, or blood loss = 500ml; 7) Known to be allergic to any component of the study drug (main components: FSH, LH; Excipients: lactose, polysorbate 20, sodium dihydrogen phosphate, disodium hydrogen phosphate, etc.); 8) Contraindications for the use of high-purity urinary gonadotropins (including: breast tumors); 9) Application of any drugs within 2 weeks prior to the first dose of study drug; 10) Subjects with a fertility plan within 6 months; 11) Causes For any reason, the procedures specified in the research protocol cannot be completed according to the requirements of the protocol, including planned visits and laboratory tests; 12) Any other factors that the researcher considers inappropriate for the subject t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-8 of FSH;AUC0-t of FSH;Cmax of FSH; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax of FSH;t1/2 of FSH;AUC0-8 of LH;AUC0-t of LH;Cmax of LH;Tmax of LH;t1/2 of LH;MRT of LH;MRT of FSH;?z of FSH;CL/F of FSH;Vz/F of FSH;?z of LH;CL/F of LH;Vz/F of LH; | — |
Countries
China
Contacts
Public ContactRui Wang,Yun Cai,Hongmei Peng
Chinese PLA General Hospital
Outcome results
None listed