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
文摘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.
