Pharmacokinetics of the H₂ 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 capsule (ALTAT^®CAPSULES) in children. In single-dose PK study in pediatric patients aged between 6 to 14 years with acid-related diseases, roxatidine capsule 37.5 mg or 75 mg 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 roxatidine capsule 37.5 mg, 75 mg or 150 mg. Differences were present between the pharmacokinetic 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. The close correlation of the C_max and AUC_0-∞ to the dose per unit BSA (mg/m²) or BW (mg/kg) were also shown. In the multiple-dose study in pediatric patients, no roxatidine accumulation in plasma has been observed as was the case with previous study in adults. These data show that the pharmacokinetic profile of roxatidine in pediatric patients is similar to the profile in healthy adult volunteers when adjusted by BSA or BW.