| Title | Comparative bioequivalence study of omeprazole 20 mg under fed and fasted conditions in healthy volunteers | |
| Authors | Dimitra Charisi¹, Chrisovaladou Tsoukia¹, Stamatia Pagoni³, Maria Katsiampani¹, Spiros Kouris¹, Stefanie Stefanadi¹, Maria Tsalta¹, Nikolaos Karagiannides¹ and Michael Koupparis²
1. Mentor Laboratories S.A. Spaton Avenue 197, Pallini, Attiki, Greece 2. Laboratory of Analytical Chemistry, Department of Chemistry, University of Athens 3. General National Hospital of Athens G. Gennimatas, 1st Internal Medicine Dept. |
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| Citation | Charisi, D., Tsoukia, C., Pagoni, S., Katsiampani, M., Kouris, S. et al: Comparative bioequivalence study of omeprazole 20 mg under fed and fasted conditions in healthy volunteers, Epitheorese Klin. Farmakol. Farmakokinet. 20(2): 140-142 (2006) | |
| Publication Date | Accepted for publication: 19-20 May 2006 | |
| Full Text Language | English | |
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| Keywords | Omeprazole determination, reduction of gastric acid secretion, fed and fasted conditions. | |
| Other Terms | review article | |
| Summary | An efficient liquid chromatographic method, with ultraviolet spectrometric detection, using chloramphenicol as internal standard is described for the determination of Omeprazole in healthy volunteers. The study was performed under fed and fasted conditions. The comparison of the results among two studies demonstrated that there is no significant effect of food consumption during the study. | |
| References | 1. Diletti E., Haushke D., Stenijans V.W.: Sample size determination for bioequivalence assessment by means of confidence intervals. Int. J. Clin. Pharmacol. Ther. Toxicol. 29: 1-8 (1991)
2. Searle S.R., Speed F.M., Millekien G.A.: Population marginal means in the linear model: An alternative to least squares means. Am. Statist. 34: 216-221 (1980) 3. Physician’s Desk Reference (PDR), http://www.pdr.net, 2001 4. Kah Hay Yuen, Wai Peng Choy et al., Improved high performance liquid chromatographic analysis of omeprazole in human plasma. J. Pharmac. Biomed. Anal. 24: 715-719 (2001) 5. Cheng F.C., Ho Y.F., et al.: Determination and pharmacokinetic profile of omeprazole in rat blood, brain and bile by microdialysis and high-performance liquid chromatography, J. Chromatography A. 949: 35-42 (2002) 6. Weng N.: Bioanalytical liquid chromatography tandem mass spectrometry methods on underivatized silica columns with aqueous/organic mobile phases. J. Chromatography B 796: 209-224 (2003) 7. Diletti E., Haushke D., Stenijans V.W.: Sample size determination for bioequivalence assessment by means of confidence intervals. Int. J. Clin. Pharmacol. Ther. Toxicol. 29: 1-8 (1993) 8. Searle S.R., Speed F.M., Millekien G.A.: Population marginal means in the alternative to least square means. Am. Statist. 34: 216-221 (1980) |
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Online ISSN 1011-6575
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Articles published in this Journal are Indexed or Abstracted in: • Chemical Abstracts • Elsevier’s Bibliographic Databases: Scopus, EMBASE, EMBiology, Elsevier BIOBASE SCImago Journal and Country Rank Factor
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