The bioequivalence of nizatidine (Axid) in two extemporaneously and one commercially prepared oral liquid formulations compared with capsule.

摘要: Nizatidine (Axid) is an H2-receptor antagonist used for the treatment of acid-related gastrointestinal disorders. Given frequency these conditions in children and potential pediatric use nizatidine, oral liquid dosage formulation would provide alternative option patients unable to swallow solid forms. This study was designed as open-label, single-dose, four-way crossover trial investigate bioequivalence 150 mg nizatidine administered three formulations (a commercially prepared syrup, extemporaneous solution apple juice, suspension infant formula) relative marketed capsule formulation. Twenty-four adult subjects (ages 31.2 +/- 7.5 years; weight 71.1 11.8 kg) were enrolled, blood samples determination plasma concentrations collected prior drug administration at 19 discrete intervals over a 24-hour postdose interval. quantitated from using validated HPLC-MS assay, noncompartmental approach describe biodisposition all subjects. Significant effects observed log-normalized Cmax, AUC0-n, AUC0-infinity (p < 0.001). Further evaluation revealed that juice markedly less bioavailable than reference capsule, with 90% confidence (CIs) 0.518-0.626, 0.682-0.751, 0.696-0.763 AUC0-infinity, respectively. The remaining two demonstrated CI within guidelines established by Food Drug Administration (e.g., 0.80-1.25). Thus, formula syrup can be considered bioequivalent capsule.