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Bioequivalence study of formulation Rabiplus-XT with reference Rabium plus in healthy volunteers

Author(s): Somasekhar Penumajji1 and Varaprasad Bobbarala2*

Journal: Drug Invention Today
ISSN 0975-7619

Volume: 1;
Issue: 1;
Start page: 13;
Date: 2009;
Original page

Keywords: Chronic gastritis | Bioequivalence | High performance liquid chromatography (HPLC) | Healthy volunteers.

A randomized, two-way, crossover bioequivalence study in 12 healthy volunteers was conducted to compare the pharmacokinetic parametersof RABIPLUS-XT versus Reference Rabium Plus (Rabeprazole Sodium 20mg+Itopride HCl 150 mg SR Capsules). The blood sampleswere collected during the 48hour period after drug administration. Rabeprazole and Itopride levels in plasma were determined by highperformance liquid chromatography. The pharmacokinetic variables of area under the plasma concentration time curve, maximum concentration, time to maximum concentration, elimination half-life, and mean residence time were computed. The results of this study suggest that the two formulations are bioequivalent. After the test formulation of RABIPLUS-XT is found to be bioequivalent with the reference formulation Reference of Rabium Plus.

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