healthy Chinese
Conditions
Interventions
Sequence 1:First, levornidazole sodium chloride injection was given (200ml: 0.5 g) , then ornidazole sodium chloride injection was given (200ml: 0.5 G)
Sequence 2:First ornidazole sodium chloride injection (200ml: 0.5 G) was given, then levoornidazole sodium chloride injection (200ml: 0.5 G) was given
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Subjects who met all of the following criteria, access to this trial: 1) sign the informed consent form before the start of any related activity of the trial. 2) the age ranged from 18 to 45 years (including 18 and 45 years) . 3) the body mass index (BMI) was 19.0 ~ 24.0 kg/m2(including 19.0 and 24.0 kg/m2) . The subjects weighed no less than 50 kg. 4) the health status of the subjects was judged by their past/present medical history, physical examination, vital signs, electrocardiogram (ECG) and laboratory examination. Of these, systolic blood pressure: 90 mmhg-139 mmhg, diastolic blood pressure: 60 mmhg-89 mmhg; Pulse: 55-99 beats per minute; body temperature: 35.0-37.0 ° C.
Exclusion criteria
Exclusion criteria: Volunteers who meet one of the following criteria, not included in this trial: 1) known or suspected allergy to ornidazole or related drugs. Persons with a history of multiple and/or severe allergic reactions to drugs or food, or a history of severe allergic reactions. 2) those who had received any experimental drugs within 3 months before screening, and those who had used any drugs within 2 weeks before screening, including over-the-counter drugs, Chinese herbal medicines or vitamins. 3) the abnormal patients were found by ECG. 4) at screening, the blood pressure in the sitting position was above the systolic range of 90-139 mmhg, or the diastolic pressure was above the range of 60-89 mmhg. (the volunteers could be included in the study if at least two repeated measurements after a 10-minute rest showed that the values were within the range.) . 5) previous history of severe cardiovascular, lung, liver, kidney, blood, gastrointestinal, endocrine, immune, skin, neurological or psychiatric disorders. The researchers determined that there was any risk of confounding the results of the trial or that the use of the drug would pose a risk to the volunteers.6) a history of malignancy in any organ system in the past 5 years, whether treated or untreated, and whether there is evidence of local recurrence or metastasis. 7) laboratory examination showed clinically significant abnormality: laboratory examination of liver function, such as AST, ALT, ALP or bilirubin, showed clinically significant abnormality, suggesting liver disease or liver injury. Creatinine and urea nitrogen exceeded the upper limit of normal or urine composition was significantly abnormal. There are some clinically significant abnormalities in the routine blood test, such as anemia, leukopenia, and significant thrombocytopenia (judged by the abnormal value of laboratory test in adverse events) . Immunological abnormalities included HIV antibody positivity, hepatitis B surface antigen (HBSAG) positivity, hepatitis C antibody positivity, or syphilis antibody positivity. 8) those who donated more than 400ML blood within 3 months or suffered from massive hemorrhage due to operation, trauma, etc. (more than 400ML) . 9) researchers judged individuals with a history of alcohol or drug/chemical abuse or who tested positive for drugs or alcohol in their urine at screening. 10) women who were menstruating during the trial. 11) those who smoked more than 5 cigarettes (including nicotine replacement products) or an equal amount of tobacco products per day for the last 3 months and were unable to quit 48 hours before administration to the entire duration of the trial (including the use of nicotine gum or transdermal nicotine patches) . 12) the researchers identified communication problems with the volunteers or judged potential non-compliance or non-cooperation. 13) women who are pregnant, breast-feeding, planning to become pregnant three months before the start of the trial, as well as women who did not or refused to use an acceptable method of contraception three months before the signing of the informed consent until three months after the end of the trial; and male volunteers who refused to use an acceptable method of contraception or had a child-care plan within three months after receiving the trial drug. Acceptable methods of contraception include sterilization, Intrauterine device, oral contraceptives, or barrier methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the pharmacokinetics of levornidazole and ornidazole in healthy Chinese subjects after a single intravenous injection;to determine whether the chiral inversion of levornidazole occurs in vivo; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety of levornidazole sodium chloride injection (200ml: 0.5g); | — |
Countries
China
Contacts
Public ContactKexin Li
beijing hospital
Outcome results
None listed