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
- *Corresponding Author:
- Dr. Mario González-de la Parra
Privada Jesús del Monte
No.77, Col. Cuajimalpa, 05000
Mexico City, Mexico
E-mail: [email protected]
Received Date: May 24, 2011; Accepted Date: June 16, 2011; Published Date: June 18, 2011
Citation: Balderas-Acata JI, Ríos-Rogríguez Bueno EP, del Castillo-García S, Espinosa-Martínez C, Burke-Fraga V, et al. (2011) 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. J Bioequiv Availab 3: 077-081. doi: 10.4172/jbb.1000063
Copyright: © 2011 Balderas-Acata JI, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Pantoprazole is a proton pump inhibitor indicated for the treatment of acid-related gastrointestinal diseases such as reflux esophagitis, duodenal and gastric ulcers. The aims of this study were to compare the bioavailability and to determine the bioequivalence of a test and reference formulation of oral pantoprazole 40 mg, administered as 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 healthy Mexican adult subjects of both genders, with a 7-days washout period. Study formulations were administered after a 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 pantoprazole were determined using HPLC coupled to a UV detector. The test and reference formulations were to be considered bioequivalent 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 of Cmax, AUC0–t and AUC0–8 were 90.13% to 117.04%, 92.45% to 113.18%, and 94.50% to 108.16%, respectively. In this study a single dose of the test formulation met the regulatory requirements to assume bioequivalence, based on the rate and extent of absorption.