Anaerobic bacterial infection, amebiasis, Giardiasis, trichomoniasis
Conditions
Interventions
Test product-Reference product(fasting):The test product was taken orally on day 1 and the reference product was taken orally on day 8
Reference product - Test product(fasting):The reference product was taken orally on day 1, and the test product was taken orally on day 8
Test product-Reference product(postprandial):The test product was taken orally on day 1 and the reference product was taken orally on day 8
Reference product - Test product(postprandial):The reference product was taken orally on day 1, and the test product was taken orally on day 8
Sponsors
Cangzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Signing informed consent; (2) Male and female subjects =18 years of age; (3) Male weight =50.0 kg, female weight = 45.0 kg, and body mass index (BMI) in the range of 19.0 to 26.0 kg/m2 (including the critical value); (4) The results of physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry), 12-lead electrocardiogram examination, anterolateral chest radiograph/chest CT examination were normal or abnormal without clinical significance; (5) Female blood pregnancy test results are negative; (6) The test results of hepatitis B surface antigen, hepatitis C antibody, treponema pallidum specific antibody and AIDS antibody were normal.
Exclusion criteria
Exclusion criteria: (1) Allergic constitution or history of food or drug allergy, or known allergy to ornidazole or excipients in preparations (corn starch, microcrystalline cellulose) or other nitroimidazole; (2) Any medical history that may affect the safety of the trial or the internal process of the drug, especially the medical history of respiratory system, cardiovascular system, endocrine and metabolic system, digestive system (history of dysphagia or any gastrointestinal disease and surgical history that may affect drug absorption), urinary system, blood and lymphatic system, immune system, nervous system, etc.; (3) Any surgical history or trauma history that may affect the safety of the test or the in vivo process of the drug; (4) Currently suffering from any unstable or recurrent disease; (5) A history of drug abuse/dependence or drug use in the past 2 years; (6) Serum ethanol test was positive; (7) Urine drug screening was positive; (8) Participated in other drug clinical trials within 90 days before screening; (9) had blood loss within 90 days prior to screening (except for women during menstruation) or donated 400 mL or more, or planned to donate blood or blood components during the study period or within 3 months after the study; (10) Use of any drug that interacts with ornidazole (e.g., lithium, cimetidine, antiepileptic drugs such as phenytoin sodium and phenobarbital, vecuronium bromide, warfarin, etc.) within 30 days prior to screening or use of any drug (including Chinese herbs and health products) within 14 days prior to screening; (11) Smoking addiction (smoking 10 or more cigarettes per day) or not abstaining from smoking during the test; (12) Alcohol abuse (more than 2 units of alcohol per day, more than 14 units of alcohol per week: 1 unit = 360 mL beer or 45 mL 40% spirits or 150 mL wine), or abstaining from alcohol during the study; (13) ingested chocolate, or any food or drink containing caffeine, rich in xanthine or grapefruit within 48 hours prior to screening; (14) Have a history of needle fainting or blood fainting, or cannot tolerate blood collection by venipunction; (15) Having a birth plan (including sperm donation plan and egg donation plan), unwilling or unable to take effective contraceptive measures within 30 days before screening and six months after the end of the trial; (16) lactating women; (17) Have special requirements on diet, can not according to the requirements of diet and exercise control; (18) Inability to communicate or cooperate with medical staff due to neurological, mental illness or language disorder; (19) Other conditions considered inappropriate by the investigator to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2;?z; | — |
Countries
China
Contacts
Public ContactYangrong Wang
Cangzhou Central Hospital
Outcome results
None listed