Diseases of reproductive system
Conditions
Interventions
Sponsors
People's Hospital of Deyang City
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 45 years old (including 18 and 45 one full year of life), both men and women; (2) Male subjects with weight more than 50 kg (contain 50 kg), female subjects with weight more than 45 kg (including 45 kg); Body mass index [BMI = weight (kg)/height (m) 2] within the scope of the 19 ~ 26 kg/m2; (3) No clinical history of heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders and metabolic abnormalities; (4) Physical examination, vital signs examination (ear temperature, pulse, blood pressure), laboratory examination (blood routine, urine analysis, blood coagulation function, blood biochemistry, pregnancy, infectious disease screening), 12-lead electrocardiogram, chest orthostatic low-dose CT results are normal or abnormal; (5) Subjects should have a strong understand of the object, nature and eventuality of trial, volunteer for the trial and sign the informed consent; (6) Subjects should take effective appropriate precautions 6 months after the study, and there is no sperm or egg donation plan. (7) Subjects can communicate well with the researchers, understand and comply with the requirements of the entire study. Subjects are willing to stay in the phase I clinical research center according to the regulations, and abide by the ward hospitalization requirements.
Exclusion criteria
Exclusion criteria: (1) Have history of needlesickness, hematophobia and can't tolerate venipuncture; (2) Subjects allergic to ingredients of investigated drug and have allergic history to food, drug, pollen and vaccine; (3) A history of adrenocortical dysfunction; (4) Sujects with past or present history of clinical serious diseases, including but not limited to digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, nervous system, blood system, immune system and metabolic abnormalities; (5) Has a history of gastrointestinal surgery, vagotomy, intestinal resection or any surgical procedure that may interfere with gastrointestinal peristalsis, pH or absorption; (6) Any abnormal item in laboratory tests (blood routine, urine analysis, blood biochemistry, female pregnancy, coagulation function, infectious disease screening, etc.), chest low-dose CT and ECG examination was found and was judged as clinical significant by the research doctor within 2 weeks; (7) AST, ALT, TBIL, UA and Urea > 1.5 ULN; CREA > ULN; (8) Have unprotected sex within 14 days prior to screening, pregnant and lactating women; (9) History of prescription and illegal drug abuse; (10) Within 6 months prior to screening smoking more than five cigarettes a day and has a history of alcohol abuse, that drinking more than 14 units of alcohol a week (1 unit = 360 mL beer, or 45 mL liquor alcohol content of 40%, or 150 mL wine); (11) Drug abuse, alcohol test and tobacco test positive; (12) Blood donation or a history of acute blood loss (more than 400 mL) within 2 months, or 1 month after the end of the test plan to blood donors; (13) Participating in other clinical trials within the past 3 months; (14) Using any prescription drugs, over-the-counter medications, vitamin, health care products and herbal within 14 days before screening; (15) Any drugs that inhibit or induce liver CYP3A4 metabolism were used within 28 days prior to administration of the study drug; (16) During the screening period to the end of the study, subjects refused to stop using any food containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate, etc.); (17) Subjects have eaten pitaya, mango, grapefruit, lime, carambola or food or beverage prepared from them within 7 days before screening; (18) Significant changes in diet or exercise habits recently; (19) Subjects have special requirement on diets and cannot accept uniform diets; (20) Poor adherence or unsuitable to participate in the trial considered by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;Tmax;AUC0-t;AUC0-8;t1/2; | — |
Countries
China
Contacts
Public ContactFan Lianlian
People's Hospital of Deyang City
Outcome results
None listed