clinical pharmacokinetics
Conditions
Interventions
0.15 g:intravenous administration of a single dose of 0.15 g biapenem
0.3 g:intravenous administration of multiple dose of 0.3 g biapenem twice daily (at approximately 8:00 AM and 8:00 PM) for 5 consecutive days
0.6:intravenous administration of multiple dose of 0.6 g biapenem twice daily (at approximately 8:00 AM and 8:00 PM) for 5 consecutive days
Sponsors
Wuhan Union Hospital
Eligibility
Sex/Gender
All
Age
21 Years to 30 Years
Inclusion criteria
Inclusion criteria: All subjects enrolled in this clinical trial must be healthy nonsmokers, 18 to 40 years of age, with a body mass index (BMI) of 19 to 24 kg/m2. The ratio of male and female volunteers was 1:1. Physical and mental health will be determined by medical interview, complete physical examination, chest X-ray, 12-lead ECG, vital signs (blood pressure, heart rate, respiratory rate, and body temperature), and clinical standard laboratory tests, including hematology (red blood cell count, white blood cell with differential cell count, platelet count, hemoglobin, and hematocrit), blood chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, direct bilirubin, alkaline phosphatase, albumin, and total protein glucose), and urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, urobilinogen, nitrites, blood, and leucocytes). Subjects must to test negative for hepatitis C virus, hepatitis B-surface antigen, and HIV. Female volunteers must be required to have a negative pregnancy test at the time of screening.Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to performing any study specific procedures.
Exclusion criteria
Exclusion criteria: Volunteers were excluded if they have any clinically significant abnormality, have a history of an allergy or hypersensitivity to any chemicals, have donated blood or participated in another investigational drug study within 12 weeks before entry into this study, or have received any drug treatment within 2 weeks before the study. Volunteers with any history or evidence of a hepatic, renal, gastrointestinal, endocrine, pulmonary, hematological, cardiovascular, vascular, or collagen disease will also be excluded from this study. A history of muscle disease, nervous system disease, or a psychiatric disorder that might hinder compliance with the study protocol, as well as a history of alcohol, tobacco, or drug abuse, are also exclusion criteria. Female subjects who are pregnant, menstruating, or breastfeeding are also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Biapenem Concentrations;Adverse event;Pharmacokinetic parameter; | — |
Countries
China
Contacts
Public ContactShaojun Shi
Department of Pharmacy, Union Hospital
Outcome results
None listed