anaerobic infection
Conditions
Interventions
Group 1and Group 2:Group 1(500mg, q12h )and Group 2(750mg, q24h)
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The criteria for inclusion into the trail were healthy adult males or females between 19 and 45 years of age with a body mass index (BMI) of between 19 and 24 kg/m2. Medical history, physical examination, electrocardiogram, clinical laboratory tests at screening or renal and hepatic function tests did not reveal any abnormalities. Eligible subjects had a negative urine screen for alcohol, drugs of abuse (screening only) and were using an appropriate barrier method of contraception in addition to a second method barrier contraception being used by their partner for the study duration.
Exclusion criteria
Exclusion criteria: Subjects with a history of significant cardiovascular, hepatic, renal, hematologic, neurologic or psychiatric disorder were excluded. Subjects who were positive for human immunodeficiency virus I and II, hepatitis B surface antigen and antibody to hepatitis C virus were excluded, as were those who were not consistent with inclusion criteria for systolic blood pressure (higher than 90 mmHg, lower than 140 mmHg), diastolic blood pressure (higher than 40 mmHg, lower than 90 mmHg), pulse rate (more than 40 per minute, less than 99 per minute) or QTc (less than 450 msec). Those with a history of drug allergy or drug abuse were also excluded, as were those who had donated blood or plasma over 400 mL within 90 days of study initiation. Subjects who had participated in another clinical trial in the 60 days prior to study entry were excluded. Subjects who had used any prescription or over-the-counter medication in the 14 days prior to study onset were also excluded, as were those who had treatment with any known organ-harming agents within 90 days prior to the study. Subjects who couldn't tolerance the intravenous infused administration were also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-ECG;Blood;Urine;Blood biochemistry; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital Signs; | — |
Countries
China
Contacts
Public ContactZHANG JING
Outcome results
None listed