Healthy volunteers
Conditions
Interventions
1)fexofenadine only with water (control), 2)fexofenadine administration 0 hours after apple juice intake, 3)fexofenadine administration 3 hours after apple juice intake, 4)fexofenadine administratio
Sponsors
Dept. of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) A subject with body weight between 50 kg (inclusive) and 90 kg (exclusive) and body mass index (BMI) between 17 (inclusive) and 28 (exclusive) 2) 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 (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of fexofenadine | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions of fexofenadine | — |
Countries
Japan
Contacts
Public ContactTsutomu Kotegawa
Oita University Faculty of Medicine Department of Clinical Pharmacology and Therapeutics
Outcome results
None listed