Relative bioavailability and pharmacokinetic comparison of two different enteric formulations of omeprazole

Abstract

Abstract:In order to comply with the requirements for a drug listed in China, the study was developed to compare the pharmacokinetics and relative bioavailability of two different enteric formulations of omeprazole (OPZ) in healthy Chinese subjects. A total of 32 volunteers participated in the study. Plasma concentrations were analyzed by nonstereospecific liquid chromatography/tandem mass spectrometric (LC-MS/MS) method. After administration of a single 40-mg dose of the two OPZ formulations, the comparative bioavailability was assessed by calculating individual AUC 0-t (the area under the concentration-time curve from time zero to the last measurable concentration), AUC 0-∞ (the area under the concentration-time curve extrapolated to infinity), C max (the maximum observed concentration), and T peak (the time to C max ) values of OPZ, 5-hydroxyomeprazole (OH-OPZ), and omeprazole sulfone (OPZ-SFN), respectively. The 90% confidence intervals (CIs) of AUC 0-t , AUC 0-∞ , and C max were 85

Bioequivalence of Two Brands of Omeprazole 20 mg Gastro-Resistant Capsules in 18 Healthy Algerian Volunteers: A Pilot Study

“…In conclusion, the pharmacokinetic results of this study confirm earlier findings [4,7,16,20,21] and emphasize that it is advisable in future researches to assess the metabolic status by phenotyping subjects with an adequate test prior to conducting pharmacokinetic studies.…”

“…Because of the low bioavailability and high inter and intra individual variability in the absorption of Omeprazole, it is necessary to perform comparative bioavailability studies [3,7]. The aim of this study was to evaluate, in healthy Algerian volunteers, the rate and extent of absorption of a local generic Omeprazole formulation against that of the innovator product MOPRAL® from ASTRA ZENECA laboratories in order to evaluate the intra-subject variability of Omeprazole (Coefficient of variation intra-subject:…”

Improvement and Validation of a High-Performance Liquid Chromatography in Tandem Mass Spectrometry Method for Monitoring of Omeprazole in Plasma

“…The mean plasma concentration was higher under fasting conditions than with food 37 . These results are in line with those of previous reports on the pharmacokinetics of OME by Liu and coworkers (C max of 1330.46 ± 758.07 ng/mL) 38 . Other authors reported lower C max owing to lower doses of OME 24,39 .…”

“…Other authors reported lower C max owing to lower doses of OME 24,39 . The high inter-subject variability indicated by the error bars in Fig 2 is similar to the findings reported by other authors 22,38 , thus making them suitable for monitoring. and area values are given for OME and OME-D3.…”

Effects of different omeprazole dosing on gastric pH in non‐variceal upper gastrointestinal bleeding: A randomized prospective study

“…Separated blood plasma samples were frozen and kept at −70 °C until analysis. The plasma concentrations of OME and 5‐OH OME were determined using the modified nonstereospecific liquid chromatography/tandem mass spectrometric (LC‐MS/MS) method . These compounds were isolated using a liquid‐extraction method, and 50 μL (1 µg/mL) of internal standard (4‐desmethoxy‐OME; Ramidus AB, Lund, Sweden) was added to 100 μL of plasma.…”