Τόμος 20 (2006) – Τεύχος 2 – Άρθρο 61 – Επιθεώρηση Κλινικής Φαρμακολογίας και Φαρμακοκινητικής-Διεθνής Έκδοση – Volume 20 (2006) – Issue 2 – Article 61 – Epitheorese Klinikes Farmakologias και Farmakokinetikes-International Edition

Title Comparative bioequivalence study of roxithromycin 150mg/tablet and roxithromycin 300 mg/tablet in healthy volunteers
Authors Helen Kotsi¹, Chrisovaladou Tsoukia¹, Georgios Adamis³, Panagiota Katsimpra¹, Aggeliki Karountzou¹, Stephanie Stephanadi¹, 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., Athens, Greece

Citation Kotsi, H., Tsoukia, Ch., Adamis, G., Katsimpra, P., Karountzou, A. et al: Comparative bioequivalence study of roxithromycin 150mg/tablet and roxithromycin 300 mg/tablet in healthy volunteers, Epitheorese Klin. Farmakol. Farmakokinet. 20(2): 229-231 (2006)
Publication Date Accepted for publication: 19-20 May 2006
Full Text Language English
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Keywords Roxithromycin determination, wide spectrum antibiotic, non-linear absorption.
Other Terms review article
Summary An efficient liquid chromatographic method with ultraviolet detection, using clarithromycin as internal standard, is described for the determination of antibiotic Roxithromycin at 150 mg/tab and 300 mg/tab in healthy volunteers. The time of the observed maximum plasma concentration was the same for both drugs. Roxithromycin absorption is non linear, regarding the drug concentration.
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6. Pharmacokinetics of three single doses (150, 300 450 mg) of roxithromycin in young volunteers. Br. J. Clin. Practice 55 (Supplement): 49-50

7. Pharmacokinetics of roxithromycin and influence of H2 blockers and antacids on gastrointestinal absorption. Eur. J. Clin. Microbiol. Infect. Dis. 11: 465-468 (1992)

8. Clinical evaluation of roxithromycin 300 mg once daily as an alternative to 150 mg twice daily. Diagn. Microbiol. Infect. Dis. 15: 111S-117S (1992)

9. Determination of roxithromycin in human plasma by high – performance liquid chromatography with spectophotometric detection. J. Chromatogr. (B-Biomedical Applications) 723: 233-238 (1999)

10. Physician’s Desk Reference (PDR), www.pdr.net, Medical Economics, Thomson Healthcare, 2001

11. 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)

12. Searle S.R., Speed F.M., Millekien G.A.: Population marginal means in the linear model: An alternative to least square means. American Statistician 34: 216-221 (1980)

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