Endocrine diseases, carcinoma in situ of the prostate
Conditions
Interventions
group A:Leuprolide acetate microspheres for injection (trade name: inadone) ?
Specification: 11.25mg
Manufacturer: Takeda Pharmaceutical Company Limited
Product Lot Number: 539033
groupB:Leuprolide acetate microspheres for injection (trade name: inadone) ?
Specification: 11.25mg
Manufacturer: Takeda Pharmaceutical Company Limited
Product Lot Number: 508330
groupC:Leuprolide acetate microspheres for injection (trade name: inadone) ?
Specification: 11.25mg
Manufacturer: Takeda Pharmaceutical Company Limited
Product Lot Number: 517814
groupD:Leuprolide acetate microspheres for injection (trade name: inadone) ?
Specification: 11.25mg
Manufacturer: Takeda Pharmaceutical Company Limited
Product Lot Number: 539170
Sponsors
Wuhan Gulian Rehabilitation Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) The subject fully understands the purpose, nature, method and possible adverse reactions of the trial, voluntarily participates in the trial, and signs the informed consent form before the start of the trial; (2) Healthy male subjects aged 18~50 years old (including the cut-off value); (3) Body mass index (BMI) = weight (kg) / height 2 (m2), body mass index in the range of 19.0~26.0 (including the critical value), weight not less than 50.0 kg; (4) The subject has no birth plan from the time of signing the informed consent form to 6 months after the end of the study, and agrees to voluntarily take effective and appropriate contraceptive measures for himself and his partner during this period; (5) The subject can communicate well with the investigator, and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: (1) Those who are allergic to any component of leuprolide acetate microspheres or GnRH analogues for injection or allergic constitution (allergic constitution refers to allergies to two or more drugs, food, pollen, etc.); (2) Diseases or factors that need to be excluded due to abnormal clinical manifestations, including but not limited to nervous system, cardiovascular system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bone and other system diseases; There are factors that will endanger the safety of the subject, such as: abnormal heart rhythm or prolonged ECG QTc, etc.; or other factors that may affect the absorption, distribution, metabolism and excretion of drugs; (3) Abnormal levels of sex hormones; (4) Those with a history of epilepsy, depression or sexual dysfunction; (5) Those who have undergone major surgery within 1 month before administration, or plan to undergo surgery during the trial; (6) Those who cannot tolerate venipuncture, and those who have a history of fainting and blood sickness; (7) History of drug abuse in the 6 months prior to screening; (8) Those who donate blood or lose a large amount of blood (=450mL) within 3 months before administration, and receive blood transfusion or use blood products; or those who plan to donate blood or blood components during the trial; (9) The subject has a sperm donation plan within 6 months after the end of the study after using the study drug; (10) Use of any prescription drugs, over-the-counter drugs, health care products or Chinese herbal medicines, etc. within 14 days before administration; (11) Use of any drug that inhibits or induces liver metabolism of drugs within 30 days before administration (such as: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors – SSRIs antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines), or sex hormones (sex hormone compounds, estradiol derivatives, estrogen triol derivatives, compounds altered by estrogen, combination compounds of estrogen and progesterone, sex hormone mixture, etc.) or any other drugs (including traditional Chinese medicines) that may affect the pharmacokinetics and pharmacodynamic characteristics evaluation of the study drug (such as pregnenaiselenone, St. John's wort perforatus, etc.); (12) Those who have received any vaccine within 30 days before administration; (13) Those who smoked more than 5 cigarettes per day on average in the 30 days before screening; or those who cannot guarantee the cessation of smoking from the time of signing the informed consent form to the end of the study; (14) Those who had an average alcohol intake of more than 2 units per day in the 30 days prior to screening (1 unit = 360mL of beer with an alcohol content of 5%, or 45mL of spirits with an alcohol content of 40%, or 150mL of wine with an alcohol content of 12%); or those who cannot guarantee the cessation of alcohol consumption and alcohol products from the time of signing the informed consent form to the end of the study; (15) Long-term excessive consumption of tea, coffee and/or caffeinated beverages within 30 days before screening (more than 8 cups a day, 1 cup = 250mL); (16) The subject has eaten a special diet that may affect the pharmacokinetics of the drug within 48 hours before dosing (including dragon fruit, mango, grapefruit, lime, star fruit, chocolate or food or drink prepared by it, o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration and pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactAiju Li
Wuhan Gulian Rehabilitation Hospital
Outcome results
None listed