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Bioequivalence of Two Brands of Omeprazole 20 mg Gastro-Resistant Capsules in 18 Healthy Algerian Volunteers: A Pilot Study 被引量:1
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作者 K. Mansouri M. Ghozal +5 位作者 S. Behloul L. adda abbou a. makhlouf K. Nekhoul I. Hadjaz M. B. Mansouri 《Journal of Pharmacy and Pharmacology》 2017年第12期877-884,共8页
A randomized, two-way, crossover study was conducted in 18 fasting, healthy, algerian volunteers to compare the bioavailability of two brands of Omeprazole 20 mg Gastro-Resistant Capsules where MOPRAL (Astra Zeneca)... A randomized, two-way, crossover study was conducted in 18 fasting, healthy, algerian volunteers to compare the bioavailability of two brands of Omeprazole 20 mg Gastro-Resistant Capsules where MOPRAL (Astra Zeneca) was the reference product. The study was performed at the bioequivalence center of the national control laboratory for pharmaceuticals product. The drug was administered on two treatment days separated by one week washout period. After dosing, serial blood samples were collected for a period of 12 h. A reliable and robust LC-MS/MS (liquid chromatography-tandem mass spectrometry) method has been developed and validated for the estimation of Omeprazole in human plasma. The assay was found to be linear over the range of 5-1,000 ng/mL. The pharmacokinetical and statistical analysis was conducted with Kinetica 4.4.1. AUC0.t, AUC0-∞ and Cmax were tested for bioequivalence. No significant difference was found based on ANOVA; 90% confidence interval ([97.14%-117..85%] for AUC0.t, [97.17%-117.67%] for AUC0-∞) of test/reference ratio for these parameters were found within bioequivalence acceptance range of 80%-125%. But for the Cmax, it was not in this acceptance range [73,5%-100.54%]. The results of PK analysis suggested that the reference and test formulations of Omeprazole 20 mg Gastro-Resistant Capsules were not bioequivalent during fasting state in these healthy Algerian volunteers. 展开更多
关键词 OMEPRAZOLE BIOEQUIVALENCE LC-MS/MS pharmacokinetics.
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LIMIT CYCLES OF QUARTIC AND QUINTIC POLYNOMIAL DIFFERENTIAL SYSTEMS VIA AVERAGING THEORY
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作者 Y. Bouattia a. makhlouf 《Annals of Differential Equations》 2011年第1期70-85,共16页
We study the maximum number of limit cycles that can bifurcate from the period annulus surrounding the origin of a class of cubic polynomial differential systems using the averaging theory. More precisely,we prove tha... We study the maximum number of limit cycles that can bifurcate from the period annulus surrounding the origin of a class of cubic polynomial differential systems using the averaging theory. More precisely,we prove that the perturbations of the period annulus of the center located at the origin of a cubic polynomial differential system,by arbitrary quartic and quintic polynomial differential systems,there respectively exist at least 8 and 9 limit cycles bifurcating from the periodic orbits of the period annulus using the first order averaging method. 展开更多
关键词 limit cycle averaging method CONIC
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