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

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

Sandesh P Kamdi, Prashant J Palkar

ISRN Pharmacol. 2013;2013:347457.

PMID: 23476803

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 AUC0-∞ and Cmax were analyzed for 90% confidence intervals (CI) using ANOVA. The mean (90% CI) values for the ratio of AUC0-∞ and Cmax 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 AUC0-∞ , AUC0-t , and Cmax values, both the formulations were bioequivalent.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP164579322	Pantoprazole sodium		164579-32-2	Price

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