Bioequivalence
Conditions
Interventions
T---R:LZM003 (T)-Ovidrel(R)
R---T:Ovidrel(R)-LZM003 (T)
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects have to sign an informed consent form before starting the screening process and entering this study. The subjects who meet the following criteria can be selected. 1. Healthy male or female subjects, 18 to 40 years old, 45~75 kg, BMI between 19 ~ 26 kg /? (including the threshold value); 2. Female subjects have normal menstrual cycles. (25~34 days, including the threshold value); 3. The level of follicle-stimulating hormone(FSH),luteinizing hormone(LH),prolactin(PRL), Estrodiol(E2), Progesterone(P) of female subjects should be detected at the time of 2 to 3 days after the last menstrual period before administration.The level of follicle-stimulating hormone(FSH) of female subjects should be detected at screening period. All of these measurement should be normal or have been judged as abnormalities without clinical significance by the investigator; 4. The physiological structure of female subjects'uterus and bilateral ovary is normal; 5. All of the subjects agree that effective contraception would be carried out from the beginning to one month after the end of the trial.The effective contraception include Intrauterine device,condom,isolation cap(diaphragm ,cervical cap or dome cap) and foam / gel / film / cream / suppository which can kill sperm,or avoiding sexual behavior; 6. All of the subjects are willing and able to follow the visit, treatment, laboratory tests and other related procedures of this study; 7. Subjects participate in this trial voluntarily and sign an informed consent form.
Exclusion criteria
Exclusion criteria: The subjects can not be entered in this study if he/she meets any of the following criteria: 1. The subjects with clinically significant disease in past or has been tested during screening or enrollment. The list include disease of gastrointestinal tract\kidney\liver cardiovascular\blood\respiratory system\nervous system\mental\endocrine disorders (including known diabetes) and immune system; 2. The subjects who are suffered from a clinically significant allergy in past or present( dose no include mild asymptomatic seasonal allergies).Or the subject who is known or be suspicious of has an allergic or hypersensitivity reaction to any ingredient of the durg; 3. The result of the subjects ECG has a clinically significant abnormality(as determined by the investigator),or QT interval> 450 ms after bazett corrected; 4. The subjects Blood pressure or pulse abnormalities during screening or enrollment.(Such as systolic blood pressure less than90 mmHg or than more 140 mmHg, diastolic blood pressure less than 50 mmHg or than more 100 mmHg.); 5. The following abnormalities are present in the laboratory examination during the screening period and are still exsit before the first administration; a. Peripheral blood: WBC less than 3×10^9/L, NEUT# less than 1.5×109/L, PLT less than 90×10^9/L,HGB of male subjects is less than 100 g/L,or HGB of female subjects is less than 90 g/L. b. ALT, AST or TBIL more than 2 times of the normal reference value upper limit; c. Cr is more than 1.5 times of the normal reference value upper limit; 6. There is any kind of clinically significant infections during screening or enrollment; 7. There is a positive result of HIV,HBsAg,HCV?Ag or TP-Ab; 8. History of malignant tumor; 9. A history of ovarian, uterine, hypothalamic or pituitary disease (except for uterine fibroids); 10. Suffering from a endocrine disorders in past or present,such as Hyperprolactinemia, polycystic ovary syndrome and ovarian insufficiency, etc.; 11. Lactating women or serum pregnancy test positive; 12. Prescription or over-the-counter medications has been used within 14 days prior to enrollment,or the time of the last dose is less than 5 half-life before the administration in this study; 13. Subjects participated in other clinical trials during 3 months prior to enrollment or prepare to join other clinical trials during the study period; 14. A history has been known for drug abuse\hobbies smoking(more than 10 cigarettes a day)\alcoholismin during 3 months before screening or in present; 15. Any abnormal result is found in nicotine testing and urinalysis; 16. The subject can not follow limitations on smoking, alcohol consumption, combination medication, and high intensity physical activity during the study period; 17. The subject has a history of blood donation or blood collection (more than 200 mL) during 3 months prior to screening,or prepare to participate in blood donation; 18. The subject has used any kind of LH\hMG\hCG preparation during 3 months prior to screening; 19. The subject has a history of ectopic pregnancy during 3 months prior to screening; 20. Any other situation that the investigator think may affect the safety of subjects and judgment of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;AUC0-8;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;T1/2;Vd;CL; | — |
Countries
China
Contacts
Public ContactRui Wang, Yun Cai
Chinese PLA General Hospital
Outcome results
None listed