anaerobic infection
Conditions
Interventions
elderly group:500mg,q12
young group:500mg,q12
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Elderly volunteers: The criteria for inclusion into the trail were healthy elderly males or females between the ages of 60 and 80 years with a body mass index (BMI) of between 19 and 24 kg/m2. Eligible subjects were those with no evidence of diseases of the major organs, chronic viral hepatitis, HIV infection, and no clinically significant biochemistry, haematology or urinalysis data abnormalities after medical history, physical examination, electrocardiogram, clinical laboratory tests. Eligible subjects were those who were willing to sign the informed consent, had a negative screening for alcohol and urine screening for controlled drugs, and did not participate in other clinical trials within 2 months. Young volunteers: The criteria for inclusion into the trail were healthy males or females between the ages of 19 and 45 years with a body mass index (BMI) of between 19 and 24 kg/m2. Eligible subjects were those with no evidence of diseases of the major organs, chronic viral hepatitis, HIV infection, and no clinically significant biochemistry, haematology or urinalysis data abnormalities after medical history, physical examination, electrocardiogram, clinical laboratory tests. Eligible subjects were those who were willing to sign the informed consent, had a negative screening for alcohol and urine screening for controlled drugs, and did not participate in other clinical trials within 2 months. For females of childbearing age, subjects should use an appropriate contraceptive method during the study and had a negative result of urine pregnancy test.
Exclusion criteria
Exclusion criteria: Elderly volunteers: Subjects with a history of significant cardiovascular, gastrointestinal, urinary, respiratory, 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. Subjects whose blood pressure or glucose was out of control after taking oral antihypertensive or antidiabetic drugs, or had clinically significant chemistry, hematology, or urinalysis data abnormalities were excluded. Those with a history of drug allergy or drug abuse, suffering serious disease effecting drug in vivo disposition 1 month before screening or who had donated blood or plasma over 400 mL within 90 days of study initiation were also excluded. Young volunteers: Subjects with a history of significant cardiovascular, gastrointestinal, urinary, respiratory, 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. Subjects whose blood pressure and pulse rate were out of the normal range of systolic pressure higher than 90 mmHg and lower than 140 mmHg, diastolic pressure higher than 60 mmHg and lower than 90 mmHg, and pulse rate greater than 40 per minute and less than 99 per minute were excluded. Subjects who had clinically significant chemistry, hematology, or urinalysis data abnormalities were excluded. Lactating women or those with a history of drug allergy or drug abuse, suffering serious disease effecting drug in vivo disposition 1 month before screening or who had donated blood or plasma over 400 mL within 90 days of study initiation were also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital Signs;12-ECG;Blood;Urine;Blood biochemistry; | — |
Countries
China
Contacts
Public ContactZHANG JING
Outcome results
None listed