Pharmacophore an International Research Journal
Bioequivalence studies are the preliminary requirement for generic products to enter in the market. International regulatory authorities require that the final quality judgment of an oral dosage form be based on its in vitro dissolution profile and its in vivo bioavailability or bioequivalence evaluation. This is an open label, balanced, randomized, two treatments, two periods, two sequences, single dose, cross-over, and bioequivalence study in (22) healthy, adult, subjects under fed conditions. Subjects was administered 20 ml of water before dosing, allowing to wet the mouth of the subject and then a single oral dose of test formulation Rizatriptan orally disintegrating tablets 10 mg or reference formulation Maxalt MLT® 10 mg (Rizatriptan benzoate) orally disintegrating tablets was placed on the tongue and allowed to disintegrate/ dissolve and swallowed with saliva under low light condition 30 min after initiation of a standardized high fat high calorie breakfast in period I. Similar procedure was followed in period II. Subjects received alternate treatments at the end of the study. The study was conducted according to the approved protocol, SOPs and ICH-GCP guidelines and applicable regulatory guidelines. A validated bio analytical method was adopted for conduct of analysis of the plasma samples of the study, which was selective, sensitive and cost effective. Based on geometric mean ratio of log transformed data and 90% confidence interval of test and reference product for Cmax, AUC0-t and AUC0-∞, it is concluded that the ratio and extent of absorption of test and reference product are similar.
