Pharmacokinetics and Comparative Bioavailability of Two Metformin Formulations after Single-Dose Administration in Healthy Subjects

Clinical Drug Investigation

Volumn 23, Issue 11, 2003, Pages 743-749

  Atanasova, Ivanka ^a   Bozhinova, Kristina ^b   Todorova, Denitza ^c   Terziivanov, Dimiter ^b,d  

^a Ministry of Health Sofia   (Bulgaria)

^b UNIVERSITY HOSPITAL ALEXANDROVSKA   (Bulgaria)

^c Sopharma Pharmaceuticals   (Bulgaria)

^d UNIVERSITY HOSPITAL ST IVAN RILSKI   (Bulgaria)

Author keywords

[No Author keywords available]

Indexed keywords

METFORMIN; ORAL ANTIDIABETIC AGENT; SIOFOR;

ADULT; AREA UNDER THE CURVE; ARTICLE; DIABETES MELLITUS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG METABOLISM; FEMALE; HUMAN; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; NORMAL HUMAN; PRIORITY JOURNAL;

EID: 0242593953     PISSN: 11732563     EISSN: None     Source Type: Journal    
DOI: 10.2165/00044011-200323110-00007     Document Type: Article

References (15)

1. Cusi K, DeFronzo R. Metformin: a review of its metabolic effects. Diabetes Rev 1998; 6 (2): 89-131
2. Bailey C. Metformin: an update. Gen Pharmacol 1993; 24: 1299-309
3. Turner R, Cull C, Holman R, for the United Kingdom Prospective Diabetes Study Group: United Kingdom prospective diabetes study (UKPDS) 17: a 9-year update of a randomized, controlled trial on the effect of improved metabolic control on complications in non-insulin-dependent diabetes mellitus. Ann Intern Med 1996; 124 (1 pt 2): 136-45
4. Scheen AJ. Clinical pharmacokinetics of metformin. Clin Pharmacokinet 1996; 30: 359-71
5. Najib N, Idkaidek N, Beshtawi M, et al. Bioequivalence evaluation of two brands of metformin 500mg tablets (Dialon & Glucophage) in healthy human volunteers. Biopharm Drug Dispos 2002; 23: 301-6
6. Yuen KH, Wong JW, Billa N, et al. Bioequivalence of a generic metformin tablet preparation. Int J Clin Pharmacol Ther 1999; 37 (7): 319-22
7. Yuen KH, Peh K. Simple high-performance liquid chromatographic method for the determination of metformin in human plasma. J Chromatogr B Biomed Sci Appl 1988; 710: 243-6
8. Guidance for industry. Bioavailability and bioequivalence studies for orally administered drug products: general considerations. Available from URL: www.fda.gov/cder/guidance/ 5356fnl.doc [Accessed 2003 Mar]
9. Hauschke D, Steinjans V, Diletti E, et al. A distribution-free procedure for statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol 1990; 28: 72-3
10. Sauter R, Steinijans VW, Diletti E, et al. Presentation of results from bioequiavlence studies. Int J Clin Pharmacol Ther Toxicol 1992; 30: S7-13
11. Wijnand HP. Updates of bioequivalence programs (including statistical power approximation by Student's t). Comput Methods Programs Biomed 1994; 42: 275-81
12. Steinijans V, Sauter R, Hauschke D, et al. Reference tables for the intrasubject coefficient of variation in bioequivalence studies. Int J Clin Pharmacol Ther 1995; 33: 427-30
13. Tucker G, Casey C, Phillips P, et al. Metformin kinetics in healthy subjects and in patients with diabetes mellitus. Br J Clin Pharmacol 1981; 12: 235-46
14. Luft D, Schmulling R, Eggstein M. Lactic acidosis in biguanide-treated diabetes: a review of 330 cases. Diabetologia 1983; 24: 351-4
15. Caille G, Lacasse Y, Raymond M. Bioavailability of metformin in tablet form using a new high pressure liquid chromatography assay method. Biopharm Drug Dispos 1993; 14: 257-63