التفاصيل البيبلوغرافية
| العنوان: |
Bioequivalence Study of Pantoprazole Sodium-HPBCD and Conventional Pantoprazole Sodium Enteric-Coated Tablet Formulations. |
| المؤلفون: |
Kamdi, Sandesh P., Palkar, Prashant J. |
| المصدر: |
ISRN Pharmacology; 2013, p1-4, 4p |
| مصطلحات موضوعية: |
THERAPEUTIC equivalency in drugs, SODIUM, DRUG tablets, BLOOD sampling, DRUG administration, HIGH performance liquid chromatography |
| مستخلص: |
The objective of this study was to investigate the bioequivalence of two formulations of 40mg 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. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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