Healthy volunteers
Conditions
Interventions
A single intravenous dose of ceftizoxime sodium 0.5 g administered over 30 min
Sponsors
Department of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy male and female volunteers, age ranged 20 to 50 years (both inclusive) 2)A subject with body weight between 45 kg (inclusive) and 80 kg (inclusive) for female, and between 50 kg (inclusive) and 90 kg (inclusive) for male, and body mass index (BMI) between 17 (inclusive) and 28 (inclusivee) for both gender. 3)Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests (including the case that the investigator considers the deviation to be irrelevant for the purpose of the study)
Exclusion criteria
Exclusion criteria: 1)A subject with history of allergies including study drug or any other food and drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies 2)A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, gastrointestinal, respiratory (including asthma and COPD), endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease 3)A subject who shows a positive reaction to any one of serology tests (hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody). 4)A subject with a history of surgery (except simple appendectomy or repair of hernia) 5)A subject with history of drug abuse or positive urine drug screening test 6)A subject who has taken any prescribed medication or herbal compounds within 14 days prior to the study drug administration. In addition, a subject who has taken any over-the-counter drug or vitamin supplements within 7 days prior to the study drug administration (However, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied.) 7)A subject who consumes more than 7 units of alcohol (140g) per week or unable to stop drinking throughout the study period 8)A smoker (except for whom quitted smoking prior to the drug administration for at least 3 months) 9)A subject who heavily takes caffeine or caffeine-containing products, grapefruit, grapefruit juice, grapefruit-containing products 10)A female subject who are pregnant or breast feeding 11)A female subject who does not agree to use routinely adequate contraception* from signing of informed consent throughout the duration of the study and for 30 days after the last dose of study drug despite having a childbearing potential and being sexually active with a non-sterilized male partner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of ceftizoxime: -Cmax: maximum measured serum concentration over the time span specified -AUClast: the area under the serum concentration versus time curve, from time 0 to the last measurable concentration -AUCinf: the area under the serum concentration versus time curve from time 0 to infinity -t1/2: the time necessary for the serum concentration of drug to decrease by half -Vd: the total volume of distribution -CLtot: the total body clearance -CLren: the renal clearance | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactTsutomu Kotegawa
Oita University Faculty of Medicine Department of Clinical Pharmacology and Therapeutics
Outcome results
None listed