Table of Contents
ISRN Pharmacology
Volume 2013, Article ID 347457, 4 pages
http://dx.doi.org/10.1155/2013/347457
Research Article

Bioequivalence Study of Pantoprazole Sodium-HPBCD and Conventional Pantoprazole Sodium Enteric-Coated Tablet Formulations

Medical Services Department, Akumentis Healthcare Ltd., 204 Second Floor, G-Corp Tech Park, Kasarvadavali, Near Hypercity, Ghodbunder Road, Thane (West), Maharashtra 400 615, India

Received 26 December 2012; Accepted 11 January 2013

Academic Editors: T. Irie and T. B. Vree

Copyright © 2013 Sandesh P. Kamdi and Prashant J. Palkar. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

The objective of this study was to investigate the bioequivalence of two formulations of 40 mg pantoprazole sodium enteric-coated tablets: Tripepsa as the test and Pantocid as the reference. The two products were administered as a single oral dose according to a randomized two-phase crossover with a 1-month washout period in 25 healthy Indian volunteers. After drug administration, serial blood samples were collected over a period of 30 hours. Plasma pantoprazole concentrations were measured by high-performance liquid chromatography with UV detection. Pharmacokinetic parameters were analyzed based on noncompartmental analysis. The logarithmically transformed data of and were analyzed for 90% confidence intervals (CI) using ANOVA. The mean (90% CI) values for the ratio of and values of the test product over those of the reference product were 90.21 (83.69–97.24) and 108.68 (100.21–117.86), respectively (within the bioequivalence range of 80–125%). On the basis of pharmacokinetic parameters including , , and values, both the formulations were bioequivalent.