Pharmacokinetics and Bioequivalence Study of Two Proton Pump Inhibitor Products
Journal Title: Journal of Pharmaceutical Research International - Year 2016, Vol 13, Issue 6
Abstract
Omeprazole (OPZ) efficiently suppresses acid secretion in the parietal cells of the stomach. It is widely recommended as proton pump inhibitor (PPI) in Egypt. Presence of many products containing omeprazole available in the Egyptian market raises questions of generic substitution and/or therapeutic equivalence. The aim of the study was to compare the pharmacokinetic parameters and relative bioequivalence properties of two oral omeprazole formulations, Gastroloc® and Pepzol® enteric coated capsules, in healthy subjects. A randomized, two-way crossover study was conducted to study the pharmacokinetic parameters of the OPZ products in 24 healthy human volunteers in compliance with the Declaration of Helsinki and ICH guidelines. After oral administration and at specified time intervals, blood samples were collected and analyzed for plasma OPZ content using a validated HPLC method. The Pharmacokinetic parameters such as AUC0-12, Cmax, Tmax, t1/2 and elimination rate constant were determined from plasma concentration-time profile for both formulations by a non-compartmental method. The statistical analysis of the data obtained in this study showed no significant difference between the tested OPZ products. The results indicated that the tested products have similar bioavailability profiles and therefore can be considered bioequivalent based on the obtained data of AUC, Cmax, and Tmax.
Authors and Affiliations
Ehab Ibrahim Taha, Fathy Ibrahim Abd-Alla
Keywords
Related Articles
- EP ID EP342518
- DOI 10.9734/BJPR/2016/29952
- Views 78
- Downloads 0
In vitro and In vivo Antitrypanosomal Effects of Petroleum Ether, Chloroform and Methanol Extracts of Artemisia maritima Linn
Petroleum ether, chloroform and methanol extracts of the whole plant of Artemisia maritima Linn were studied in vitro and in vivo for antitrypanosomal activity against Trypanosoma brucei brucei in Swiss albino mice. The...
Biosynthesis of Silver Nanoparticles Using Callus Extract of Catharanthus roseus var. alba and Assessment of Its Antimicrobial Activity
Objective: To express a cost efficacious and environment friendly method for the green synthesis of silver nanoparticles (AgNPs) from Catharanthus roseus var. alba (C. roseus var. alba) callus extract. Methodology: The...
Efficacy of Vitamin B6 on Pregnancy Outcomes: A Randomized Clinical Trial
Background: Postpartum depression is a common and disabling disorder. A low level of vitamin B6 might theoretically causes symptoms of depression. The aim of this study was to investigate the effect of vitamin B6 on Preg...
Effect of Ethanolic Leaf Extract of Psidium guajava Linn. (Guava) in Alloxan-Induced Diabetic Rats
Effect of water – soluble components of ethanolic leaf extract of Psidium guajava Linn. on blood glucose and cholesterol levels in alloxan-induced diabetic male albino wistar rats was evaluated. A total of 30 male albino...
Preliminary Studies on Some Medicinal Plants in Girei, Adamawa State of Nigeria
Ten medicinal plants’ parts (roots, stembarks, and leaves) were studied to assert their suitability for use in pharmaceutical industries as raw materials. The presence (qualitative analysis), concentration (quantitative...