title: Pharmacokinetics of the H(2) blocker roxatidine acetate hydrochloride in pediatric patients, in comparison with healthy adult volunteers.
abstract: Clinical studies were conducted to investigate the pharmacokinetics of roxatidine acetate hydrochloride capsules (ALTAT(®) CAPSULES) in children. In a single-dose pharmacokinetic (PK) study in pediatric patients aged between 6 and 14 years with acid-related diseases, 37.5 mg or 75 mg roxatidine capsules were given orally, and blood samples were collected to determine the plasma roxatidine concentrations. Meanwhile, a single-dose PK study in healthy adult volunteers was newly conducted; subjects were given 37.5 mg, 75 mg or 150 mg roxatidine capsules. Differences were present between the PK parameters in pediatric patients and those in healthy adult volunteers. However, the CL/F and Vd/F adjusted by body surface area (BSA) or body weight (BW) were comparable. A close correlation of the C(max) and AUC(0-∞) to the dose per unit BSA (mg/m(2)) or BW (mg/kg) was also shown. In the multiple-dose study in pediatric patients, no roxatidine accumulation in plasma was observed, as was the case with a previous study in adults. These data show that the PK profile of roxatidine in pediatric patients is similar to the profile in healthy adult volunteers when adjusted by BSA or BW.
authors.affiliation: National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Hidefumi
authors.initials: H
authors.lastname: Nakamura
authors.forename: Hisashi
authors.initials: H
authors.lastname: Kawashima
authors.forename: Rieko
authors.initials: R
authors.lastname: Azuma
authors.forename: Ikuya
authors.initials: I
authors.lastname: Sato
authors.forename: Koji
authors.initials: K
authors.lastname: Nagao
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Miyazawa
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001830:Body Surface Area; D001835:Body Weight; D002214:Capsules; D002648:Child; D054796:Drug Dosage Calculations; D005260:Female; D006635:Histamine H2 Antagonists / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D006801:Humans; D007564:Japan; D008297:Male; D008657:Metabolic Clearance Rate; D008954:Models, Biological; D010880:Piperidines / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D015203:Reproducibility of Results
chemical_list: D000897:Anti-Ulcer Agents; D002214:Capsules; D006635:Histamine H2 Antagonists; D010880:Piperidines; C053742:roxatidine acetate