Infection
Conditions
Interventions
Group A:Phase 1: Subjects receive intravenous infusion of 500 mg of morinidazole
Phase 2: Subjects received 100 mg of Tenofovir once daily for 7 days, followed by intravenous infusion of 500 mg of morinidazole
Group B:Phase 1: Subjects received 100 mg of Tenofovir once daily for 7 days, followed by intravenous infusion of 500 mg of morinidazole
Phase 2: Subjects receive intravenous infusion of 500 mg of morinidazole.
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Both men and women; 2. Aged 18 to 40 years old; 3. Body mass index [BMI = weight (kg)/height (m) 2] within the scope of the 19 ~ 26 kg/m2; 4. According to past medical history, comprehensive physical examination and laboratory test, the researchers identified as healthy subjects; 5. Subject should have a strong understand of the object, nature and eventuality of trial, volunteer for the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Subject can't tolerate venipuncture; 2. Allergic constitution: the persons allergic to two or more medicines, food and pollen or ingredients of investigator product; 3. Any medical history of cardiovascular, hepatic, kidney, gastrointestinal tract, and nervous system, metabolic disturbance, etc.; 4. Hematology screening for HIV antibodies or HBV surface antigen or HCV antibody or TP antibody positive; 5. Women who are pregnant, pregnant, or plan to become pregnant in the near future; 6. The pregnancy test positive; 7. Male subjects did not take effective contraceptive measures or their spouse planned to conceive in the next six months; 8. Mental or legal disability; 9. History of prescription drug abuse and / or illicit drug abuse in the past 6 months; within 6 months prior to screening has a history of alcohol abuse, that drinking more than 14 units of alcohol a week (1 = 12 ounces or 360 mL beer, 1.5 ounces or 45 mL liquor alcohol content of 40%, 5 oz or 150 mL wine); 10. Within 6 months prior to screening smoking more than five cigarettes a day; 11. Drug abuse or alcohol test positive; 12. Subjects have a history of hospitalization or surgery within 3 months before screening history (except appendicitis); 13. Participating in other clinical trials within the past 3 months; 14. Blood donation or a history of acute blood loss (more than 400 mL) or 1 months after the end of the test plan to blood donors; 15. Use any other drugs within 2 weeks before the trial; 16. Subjects who drink strong tea, coffee and/or caffeinated drinks more than 1 L every day; 17. Subjects cannot understand the content of the informed consent and other do not accord with standard of trial; 18. Unsuitable to participate in the trial considered by the researchers (such as weak, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUCinf; | — |
Countries
China
Contacts
Public ContactShentu Jianzhong
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed