title: The Pharmacokinetic Exposure to Fexofenadine is Volume-Dependently Reduced in Healthy Subjects Following Oral Administration With Apple Juice.
abstract: Pharmacokinetic exposures to fexofenadine (FEX) are reduced by apple juice (AJ); however, the relationship between the AJ volume and the degree of AJ-FEX interaction has not been understood. In this crossover study, 10 healthy subjects received single doses of FEX 60 mg with different volumes (150, 300, and 600 mL) of AJ or water (control). To identify an AJ volume lacking clinically meaningful interaction, we tested a hypothesis that the 90% confidence interval (CI) for geometric mean ratio (GMR) of FEX AUCAJ /AUCwater is contained within a biocomparability bound of 0.5-2.0, with at least one tested volume of AJ. GMR (90% CI) of AUCAJ 150mL /AUCwater , AUCAJ 300mL /AUCwater , and AUCAJ 600mL /AUCwater were 0.903 (0.752-1.085), 0.593 (0.494-0.712), and 0.385 (0.321-0.462), respectively. While a moderate to large AJ-FEX interaction is caused by a larger volumes of AJ (e.g., 300 to 600 mL), the effect of a small volume (e.g., 150 mL) appears to be not meaningful.
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University, Japan.
authors.forename: J
authors.initials: J
authors.lastname: Luo
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University, Japan.|General Clinical Research Center (GCRC), Oita University Hospital, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Imai
authors.affiliation: Department of Mathematics and Statistics, Faculty of Medicine, Oita University, Japan.|General Clinical Research Center (GCRC), Oita University Hospital, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Ohyama
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University, Japan.|General Clinical Research Center (GCRC), Oita University Hospital, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Hashimoto
authors.affiliation: Clinical Pharmacology Center, Oita University Hospital, Japan.|General Clinical Research Center (GCRC), Oita University Hospital, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Hasunuma
authors.affiliation: General Clinical Research Center (GCRC), Oita University Hospital, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Inoue
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Kotegawa
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Ohashi
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University, Japan.|Clinical Pharmacology Center, Oita University Hospital, Japan.|General Clinical Research Center (GCRC), Oita University Hospital, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Uemura
mesh_terms: D000284:Administration, Oral; D001628:Beverages; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D027845:Malus; D016593:Terfenadine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics
chemical_list: D016593:Terfenadine; C093230:fexofenadine