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Bioavailability of Two Coated-Tablet Formulations of a Single Dose of Pantoprazole 40 mg: An Open-Label, Randomized, Two-Period Crossover, Comparison in Healthy Mexican Adult Volunteers

Author(s): Juana Isabel Balderas-Acata | Esteban Patricio Ríos-Rogríguez Bueno | Sofía del Castillo-García | Clara Espinosa-Martínez | Victoria Burke-Fraga | Victoria Burke-Fraga

Journal: Journal of Bioequivalence & Bioavailability
ISSN 0975-0851

Volume: 3;
Issue: 5;
Start page: 77;
Date: 2011;
Original page

Keywords: Pantoprazole | Bioequivalence | Bioavailability | Pharmacokinetics | HPLC

Pantoprazole is a proton pump inhibitor indicated for the treatment of acid-related gastrointestinal diseasessuch as reflux esophagitis, duodenal and gastric ulcers. The aims of this study were to compare the bioavailabilityand to determine the bioequivalence of a test and reference formulation of oral pantoprazole 40 mg, administeredas a coated tablet, and to generate data regarding the oral bioavailability of this drug in the Mexican population.This single-dose, randomized-sequence, open-label, 2-period crossover study was conducted on a total 34 healthyMexican adult subjects of both genders, with a 7-days washout period. Study formulations were administered aftera 10-hour overnight fast. For pharmacokinetic analysis, blood samples were drawn at 0 (baseline), 0.5, 0.75, 1,1.25, 1.5, 1.75, 2.0, 2.5, 3, 3.5, 4, 5, 6, 8, and 10 hours after administration. Plasma concentrations of pantoprazolewere determined using HPLC coupled to a UV detector. The test and reference formulations were to be consideredbioequivalent if the 90% CIs for the geometric mean test/reference ratios were within a predetermined range of 80%to 125%.The estimated pharmacokinetic parameters of pantoprazole for the reference (Pantozol®) and test (Prazolan®)formulations were Cmax (3448 ± 1214 ng/ml, 3610 ± 1344 ng/ml); AUC0–t, (5521± 2454 ng•h /ml, 5720 ± 2527 ng•h /ml); and 6097 ± 2415 ng•h /ml, 6292 ± 2548 ng•h /ml), respectively The 90% CIs for the geometric mean ratios ofCmax, AUC0–t and AUC0–∞ were 90.13% to 117.04%, 92.45% to 113.18%, and 94.50% to 108.16%, respectively. Inthis study a single dose of the test formulation met the regulatory requirements to assume bioequivalence, based onthe rate and extent of absorption.
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