Bioequivalence study of rabeprazole sodium on healthy human volunteers.

Author(s): Mondal U, Ganesan M, Pal TK, Jayakumar M, Chattaraj TK, Roy K, Banerjee SN

Affiliation(s): Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata.

Publication date & source: 2004-01, J Indian Med Assoc., 102(1):26, 28, 30.

Publication type: Clinical Trial; Randomized Controlled Trial

The newly developed proton pump inhibitor rabeprazole sodium is expected to have beneficial effects in the treatment of peptic ulcer. The pharmacokinetic parameters (C(max), AUC(o-t), t(max)) of this drug have been evaluated to compare the single dose (20 mg) bioavailability of rabeprazole sodium with the standard reference. High performance liquid chromatography (HPLC) coupled with UV detector set at 280 nm has been used to determine plasma concentration of 12 human volunteers as per Drugs Controller General of India (DCGI) guidelines. The method has been validated over a linear range of 20-480 ng/ml from plasma. The minimum quantifiable concentration was set at 10 ng/ml [co-efficient of variance (CV) < 10%]. By comparing AUC(o-t) the relative bioavailability of test preparation has been found to be 100.88% of that of reference preparation.