Prostate cancer
Conditions
Interventions
Reference preparation group:Subjects were subcutaneously injected with the reference preparation
Sponsors
The Affiliated Hospital of Changchun University of Chinese Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1) Subjects who sign the Informed Consent Forms (ICFs) and have a full understanding of the study content, process and possible adverse reactions before the study. (2) Subjects and their parterres who have no pregnancy plan and voluntarily adopt effective birth controls for the next 6 months. (3) Healthy male subjects aged 18-40 years old (inclusive). (4) Subjects with the body weight = 50.0 kg, body mass index (BMI) within the range of 20.0-24.0 kg/m2, including cut points, BMI=body weight (kg)/height2 (m2).
Exclusion criteria
Exclusion criteria: (1) Subjects who have the medical history of disorders in nervous system, mental system, respiratory system, cardiovascular system, digestive system, lymphatic system, endocrine system, skeletal muscle system, urinary system, and metabolic abnormalities, and major organ diseases. (2) Subjects who showed CS in clinical laboratory tests (hematology, urinalysis, blood biochemistry, virology test, thyroid function), vital signs, physical examinations and other relevant examinations in the screening phase. (3) Subjects who have 12-lead ECG results in the screening phase: atrioventricular block or QRS interval >120 ms or QTc interval =440 ms, or other CS. (4) Subjects who are abnormal in the concentrations of testosterone, luteinizing hormone and follicle stimulating hormone in the screening phase. (5) Subjects who have clinically significant allergic reaction history or allergy to leuprorelin, synthetic LH-RH or LH-RH derivatives, or excipients of the investigational drug. (6) Subjects who have the history of hypertension, diabetes, hyperuricemia, epilepsy, urinary retention, depression, or sexual dysfunction. (7) Subjects who have the history of blood fainting and needle fainting, inability to tolerate blood collection by intravenous indwelling needle or known severe bleeding tendency, or skin inflammation at administration and peripheral sites or skin abnormalities interfering with administration. (8) Subjects who have consumed more than 14 standard units of alcohol per week (one standard unit contains 14 g of alcohol, e.g., 360 mL of beer is equivalent to 5% alcohol or 45 mL of spirits is equivalent to 40% alcohol or 150 mL of wine is equivalent to 12% alcohol) within 3 months prior to the study, or are unable to abate during the study, or are positive in breath test for alcohol. (9) Subjects who have smoked more than 5 cigarettes per day within 3 months before the study, or who did not agree to prohibit using any tobacco products during the study. (10) Subjects who have had a history of drug abuse in the past five years or used drugs in the 3 months before the study; or subjects who are positive in the urine drug abuse screening test. (11) Subjects who have donated or lost much blood ( > 400 mL) within 3 months before the study, or plan to donate blood or blood components during the study or within 3 months at the end of the study. (12) Subjects who have participated in the clinical study of other drugs within 3 months prior to plan to participate in other clinical study during the study. (13) Subjects who have had surgery within 3 months prior to the study or plan to have surgery during the study. (14) Subjects who have received live attenuated vaccines within 1 month before the study or plan to receive the vaccines during the study or within 12 weeks at the end of the last blood collection. (15) Subjects who have used leuprorelin or relin-based drugs within the 3 months prior to the study, or used any prescription, over-the-counter, vitamin or herbal products within the 14 days prior to the study. (16) Subjects who have any drug that inhibits or induces liver metabolism of drugs (e.g., inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitor: SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives, hypnotics, verapamil, fluoroquinolones, antihistamines), or sex hormones (sex hormone compounds, estradiol derivatives, estrogen-triol derivatives, compounds altered
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC7-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8;CDay28;Luteinizing hormone(LH),Follicle-stimulating hormone(FSH);Number and proportion of subjects whose serum testosterone concentration reached the trend level on the 28th day after administration;AE; | — |
Countries
China
Contacts
Public ContactYang Haimiao
The Affiliated Hospital of Changchun University of Chinese Medicine
Outcome results
None listed