| Title | Bioequivalence study of glimepiride 4 mg/tablet and amaryl 4 mg/tablet in healthy volunteers: high risk to low glucose level in volunteer’s blood because of guideline order | |
| Authors | Helen Kotsi¹, Chrisovaladou Tsoukia¹, Thomas Katsaros³, Maria Kounoukla¹, 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, Endocrinology Department, Athens, Greece |
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| Citation | Kotsi, H., Tsoukia, Ch., Katsaros, Th., Kounoukla, M., Karagiannides, N. et al: Bioequivalence study of glimepiride 4 mg/tablet and amaryl 4 mg/tablet in healthy volunteers: high risk to low glucose level in volunteer’s blood because of guideline order, Epitheorese Klin. Farmakol. Farmakokinet. 20(2): 220-222 (2006) | |
| Publication Date | Accepted for publication: 19-20 May 2006 | |
| Full Text Language | English | |
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| Keywords | Glimepiride determination, antidiabetic drug, hypoglycaemia. | |
| Other Terms | review article | |
| Summary | An efficient liquid chromatographic method with ultraviolet detection, using clobazam as internal standard, is described for the determination of antidiabetic Glimepiride at 4mg/tab in healthy volunteers. The high value of Glimepiride concentration led to hypoglycaemic events in a certain number of volunteers. | |
| References | 1. Physician’s Desk Reference (PDR), 2001 http://www.pdr.net
2. Badian M. et al.: Determination of the absolute bioavailability of Glimepiride a new sulphonylurea. Int. J. Clin. Pharmacol. Ther. Toxicol. 30: 481-482 (1992) 3. Lehr K.H., et al.: Simultaneous determination of the sulphonylurea glimepiride and its metabolites in human serum and urine by HPLC after pre column derivatization. J. Chromatog. B 526: 497-505 (1990) 4. Badian M., et al.: Absolute bioavailability of Glimepiride after oral administration. Drug Metabol. Drug Interact. 11: 331-339 (1994) 5. Malerczyk V., et al.: Dose linearity assessment of Glimepiride tablets in healthy volunteers, Drug Metabol Drug Interact 1994; 11(4): 341-357 (1994) 6. Niemi M., et al.: Glyburide and Glimepiride pharmacokinetics in subjects with different CYP2C9 genotypes. Clin. Pharmacol. Ther. 72: 326-332 (2002) 7. Altinoez S., et al.: Analysis of Glimepiride by using derivative UV spectrophotometric method. J. Pharm. Biomed. Anal. 24: 507-515 (2001) 8. 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) 9. Searle S.R., Speed F.M., Millekien G.A.: Population marginal means in the linear mode: An alternative to least square means. American Statistician 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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