title: Bioequivalence Study of Pantoprazole Sodium-HPBCD and Conventional Pantoprazole Sodium Enteric-Coated Tablet Formulations.
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.
authors.affiliation: Medical Services Department, Akumentis Healthcare Ltd., 204 Second Floor, G-Corp Tech Park, Kasarvadavali, Near Hypercity, Ghodbunder Road, Thane (West), Maharashtra 400 615, India.
authors.forename: Sandesh P
authors.initials: SP
authors.lastname: Kamdi
authors.forename: Prashant J
authors.initials: PJ
authors.lastname: Palkar