Effect of timing of apple juice intake on the pharmacokinetics of fexofenadine: an open-label, randomized study in healthy volunteers
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000011034
- Lead Sponsor
- Dept. 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
- Male
- Target Recruitment
- 8
Not provided
1) A subject with history of allergies including study drug (fexofenadine) or other drug allergies, or history of clinically significant allergies 2) A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, gastrointestinal, respiratory, 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 has participated in any other clinical trial either for investigational or marketed drugs within 8 weeks before the study drug administration 8)A subject who has donated or had loss of 400 mL or more of blood within 8 weeks prior to start of administration of study drug 9)A subject who consumes more than 7 units of alcohol (140g) per week or unable to stop drinking throughout the study period 10)A smoker (except for whom quitted smoking prior to the drug administration for at least 3 months) 11)A subject who heavily takes caffeine or caffeine-containing products, grapefruit, grapefruit juice, grapefruit-containing products
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters of fexofenadine
- Secondary Outcome Measures
Name Time Method Adverse reactions of fexofenadine