Proven or highly suspected infection caused by sensitive bacteria
Conditions
Interventions
Group of elderly subjects:Intravenous infusion of 1 g for a duration of 60 minutes (± 5 minutes).
Group of young healthy subjects:Intravenous infusion of 1 g for a duration of 60 minutes (± 5 minutes).
Sponsors
Guangzhou Panyu District Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Elderly subjects 1) Subjects who can understand and are willing to strictly abide by the clinical trial protocol to complete the trial and sign the informed consent form. 2) Male and female subjects aged = 65 years with appropriate sex ratios; 3) Male weight= 50.0 kg, female weight= 45.0 kg; body mass index (BMI) between 18.0 and 30.0 kg/m2 (including cut-off values); 4) Those who do not have a history of serious diseases or major surgery in cardiovascular, neurological, psychiatric, digestive, respiratory, urinary, endocrine, immune and other systems, or although they have relevant medical history or surgical history, the investigator judges that it does not affect the elimination process of the test drug in vivo; 5) The results of physical examination, vital signs, 12-lead electrocardiogram, laboratory tests, imaging and ultrasound during the screening period are normal or abnormal and have no clinical significance, or although the abnormalities are clinically significant, the investigator determines that they are related to age and chronic diseases, and the safety risk of subjects after enrollment is low, and the experimental observation indicators are not affected; 6) Fertile subjects (including partners) were childfree from 2 weeks before screening to 3 months after administration or a sperm/egg donation program and voluntary use of appropriate contraception. Young subjects 1) Subjects who can understand and are willing to strictly abide by the clinical trial protocol to complete the trial and sign the informed consent form; 2) male and female subjects aged 18-45 years inclusive, with appropriate sex ratios; 3) Male weight= 50.0 kg, female weight= 45.0 kg; body mass index (BMI) in the range of 19.0-26.0 kg/m2 (including cut-off values); 4) Those in good health and no history of serious diseases such as respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc.; 5) Subjects (including partners) have no fertility or sperm/egg donation plans from 2 weeks before screening to 3 months after administration, and voluntarily take appropriate contraceptive measures.
Exclusion criteria
Exclusion criteria: Elderly subjects 1) Those who are known to have a history of allergy to levonidazole phosphate disodium ester, levoniazole, ornidazole, other nitroimidazoles or their excipients, or have a history of previous drug, food or pollen allergies; 2) Those who have special requirements for diet and cannot accept a unified diet; 3) Difficulty in venous blood collection, unable to tolerate venous puncture, and history of needle sickness; 4) Uncontrolled or poorly controlled hyperglycemia (blood glucose > 7.0 mmol/L and/or glycosylated hemoglobin >7%); 5) uncontrolled or poorly controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure >95 mmHg); 6) Any abnormal hepatitis B virus surface antigen, hepatitis C virus antibody, HIV antibody, treponemal antibody have clinical significance; 7) Those with a history of substance abuse or positive drug screening for drugs or urine within 6 months prior to screening; 8) Regular drinkers in the 3 months prior to screening, that is, those who drank more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits or 150 mL of wine with 40% alcohol) or could not stop using any alcohol products during the test, or those with an alcohol breath test result greater than 0.0 mg/100 mL; 9) Those who donated blood or lost a large amount of blood (> 400 mL) within 3 months before screening, received blood transfusions or used blood products; 10) Those who consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day for 3 months prior to screening; 11) Those who smoked = 5 cigarettes per day within 3 months prior to screening or could not stop using any tobacco products during the trial period; 12) Those who have participated in any clinical trial in the 3 months prior to screening, or who plan to participate in other clinical trials during the trial period; 13) Those who have received any surgical history, traumatic history, or planned surgery during the trial period within 30 days prior to screening; 14) Have been vaccinated within 30 days prior to screening, or plan to be vaccinated during the trial; 15) Those who have used any drug that inhibits or induces liver metabolism of the drug within 28 days prior to screening; 16) Within 7 days before check-in, have consumed grapefruit, grapefruit, dragon fruit, mango and other fruits or related products that affect metabolic enzymes; 17) Within 48 hours before check-in, consume beverages or foods rich in xanthines, caffeinated or alcoholic beverages or foods (e.g. offal, coffee, strong tea, chocolate, cola, etc.); 18) Those who develop acute diseases from the screening stage to before administration; 19) Those that the investigator believes should not be included. Young subjects 1) Those who are known to have a history of allergy to levonidazole phosphate disodium ester, levoniazole, ornidazole, other nitroimidazoles or their excipients, or have a history of previous drug, food or pollen allergies; 2) Those who have special requirements for diet and cannot accept a unified diet; 3) Difficulty in venous blood collection, unable to tolerate venous puncture, and history of needle sickness; 4) Physical examination, vital signs, 12-lead ECG, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), imaging and ultrasound examination results, the investigator judges that the abnormality is clinically significant; 5) Any abnormal hepatitis B v
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8;Tmax;T1/2;AUC_%Extrap;?z;AE/SAE;Clinical laboratory tests; 12-lead ECG; Vital signs; | — |
Countries
China
Contacts
Public ContactYang Hui
Guangzhou Panyu District Central Hospital
Outcome results
None listed