Bioequivalence Study of Pantoprazole Sodium-HPBCD and Conventional Pantoprazole Sodium Enteric-Coated Tablet Formulations. (29th January 2013)

• Record Type: Journal Article
• Authors: Kamdi, Sandesh P.; Palkar, Prashant J.
• Other Names: Irie T. Academic Editor.; Vree T. B. Academic Editor.
• Is Part Of: ISRN pharmacology. Volume 2013(2013)
• Publication Date: 2013-01-29
• Subjects: Pharmacology -- Periodicals; Pharmacological Phenomena; Pharmacology; Pharmacology; Electronic journals; Periodical; Periodicals; Fulltext; Internet Resources; Periodicals; 615.1
• DOI: 10.1155/2013/347457
• Languages: English
• ISSNs: 2090-5165

Abstract

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 ofAUC 0 − ∞ and C max were analyzed for 90% confidence intervals (CI) using ANOVA. The mean (90% CI) values for the ratio ofAUC 0 − ∞ and C max 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 includingAUC 0 − ∞, AUC 0 − t, and C max values, both the formulations were bioequivalent.