Evaluation of the bioequivalence and pharmacokinetics of two formulations of rizatriptan after single oral administration in healthy volunteers.
The pharmacokinetic parameters of two oral formulations of rizatriptan (CAS 144034-80-0, a capsule preparation as test and rizatriptan tablet as reference), given at a single dose of 10 mg each, were compared in an open-label, randomized, single oral dose, two-period cross-over design in 20 healthy volunteers under fasting conditions. Plasma concentrations of rizatriptan were measured by a validated HPLC assay. The parametric 90% confidence intervals of the geometric mean values of the test/reference ratios were 91.9% to 101.9% (point estimate: 97.3%) for AUC(0-infinity), 93.0% to 102.2% (point estimate: 96.5%) for AUC(0-t), 90.1% to 100.0% (point estimate: 95.4%) for Cmax, being within the acceptance criteria for bioequivalence (80%-125%). Tmax values were analyzed by the nonparametric Wilcoxon test and the difference was not statistically significant. Therefore, it is concluded that the test and reference rizatriptan formulations are bioequivalent with regard to both the extent and the rate of absorption.
Chen
Jun
J
Department of Pharmaceutics, School of Pharmacy, Fenglin Campus, Fudan University, Shanghai, The People's Republic of China.
Jiang
Wen Ming
WM
Xie
Yue Ling
YL
Jin
Liang
L
Mei
Ni
N
Liang
Xin Guo
XG
D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D001794:Blood Pressure / Q000187:drug effects; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004311:Double-Blind Method; D004562:Electrocardiography / Q000187:drug effects; D006207:Half-Life; D006801:Humans; D008297:Male; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013607:Tablets; D013810:Therapeutic Equivalency; D014230:Triazoles / Q000008:administration & dosage / Q000493:pharmacokinetics*; D014363:Tryptamines
D002214:Capsules; D017366:Serotonin Receptor Agonists; D013607:Tablets; D014230:Triazoles; D014363:Tryptamines; C093622:rizatriptan