A multicenter, open-label, single-dose study to investigate the effects of the ABCC4 (MRP4) rs3765534 G>A polymorphism on the pharmacokinetics of ceftizoxime in East Asian populatio
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000009858
- Lead Sponsor
- Department of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 38
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method