Relative bioavailability and bioequivalence of metforphin hydrochloride extended-released and immediate-released tablets in healthy Chinese volunteers

European Journal of Drug Metabolism and Pharmacokinetics

Volumn 32, Issue 1, 2007, Pages 21-28

  Li, Jun ^a   Jin, Yong ^a   Wang, Ting Yu ^a   Lü, Xiong Wen ^a   Li, Yuan Hai ^a  

^a ANHUI MEDICAL UNIVERSITY   (China)

Author keywords

Bioavailability; Bioequivalence; Extended release tablet; High performance liquid chromatography; Immediate release tablet; Metformin hydrochloride

Indexed keywords

METFORMIN;

ADULT; ARTICLE; BIOEQUIVALENCE; CHINESE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG HALF LIFE; DRUG RELEASE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; ULTRAVIOLET RADIATION;

EID: 34247488674     PISSN: 03787966     EISSN: None     Source Type: Journal    
DOI: 10.1007/BF03190986     Document Type: Article

References (19)

1. Scheen A.J., Lefebvre P.J. (1998): Oral antidiabetic agents. A guide to selection. Drugs, 55, 225-236.
2. DeFronzo R.A., Goodman A.M., the Multicenter Metformin Study Group. (1995): Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. The Multicenter Metformin Study Group. N. Engl. J. Med., 333, 541-549.
3. Garber A.J., Duncan T.G., Goodman A.M., Mills D.J., Rohlf J.L. (1997): Efficacy of metformin in type II diabetes: results of a double-blind, placebo-controlled, dose-response trial. Am. J. Med., 103, 491-497.
4. Reaven G.M., Johnston P., Hollenbeck C.B., Skowronski R., Zhang J.C., Goldfine I.D., Chen Y.D. (1992): Combined metformin- sulfonylurea treatment of patients with noninsulin-dependent diabetes in fair to poor glycemic control. J. Clin. Endocrinol. Metab., 74, 1020-1026.
5. Campbell I.W. (1985): Metformin and the sulphonylureas: the comparative risk. Horm. Metab. Res. (Suppl), 15, 105-111.
6. Stumvoll M., Nurjhan N., Perriello G., Dailey G., Gerich J.E. (1995): Metabolic effects of metformin in non-insulin-dependent diabetes mellitus. N. Engl. J. Med., 333, 550-554.
7. Knowler W.C., Barrett-Connor E., Fowler S.E., Hamman R.F., Lachin J.M., Walker E.A., Nathan D.M.; Diabetes Prevention Program Research Group. (2002): Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N. Engl. J. Med., 346, 393-403.
8. Turner R., Cull C., Holman R. (1996): 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., 124 (1 pt 2), 136-145.
9. Marchetti P., Navalesi R. (1989): Pharmacokinetic-pharmacodynamic relationships of oral hypoglycaemic agents. An update. Clin. Pharmacokinet., 16, 100-128.
10. Bailey C.J., Turner R.C. (1996): Metformin. New Engl. J. Med., 334, 574-579.
11. Fujioka K., Pans M., Joyal S. (2003): Glycemic control in patients with type 2 diabetes mellitus switched from twice-daily immediate-release metformin to a once-daily extended-release formulation. Clin. Ther., 25, 515-529.
12. Hebden J.M., Gilchrist P.J., Blackshaw E., Frier M.E., Perkins A.C., Wilson C.G., Spiller R.C. (1999): Night-time quiescence and morning activation in the human colon: effect on transit of dispersed and large single unit formulations. Eur. J. Gastroenterol. Hepatol., 11, 1379-1385.
13. Huupponen R., Ojala-Karlsson P., Rouru J., Koulu M. (1992): Determination of metformin in plasma by high-performance liquid chromatography. J. Chromatogr., 583, 270-273.
14. Caille G., Lacasse Y., Raymond M., Landriault H., Perrotta M., Picirilli G., Thiffault J., Spenard J. (1993): Bioavailability of metformin in tablet form using a new high pressure liquid chromatography assay method. Biopharm. Drug Dispos., 14, 257-263.
15. Gusler G., Gorsline J., Levy G., Zhang S.Z., Weston I.E., Naret D., Berner B. (2001): Pharmacokinetics of metformin gastric-retentive tablets in healthy volunteers. J. Clin. Pharmacol., 41, 655-661.
16. Cullen E., Liao J., Lukacsko P., Niecestro R., Friedhoff L. (2004): Pharmacokinetics and dose proportionality of extended-release metformin following administration of 1000, 1500, 2000 and 2500 mg in healthy volunteers. Biopharm. Drug. Dispos., 25, 261-263.
17. Depomed Corp. (2004): Metformin extended release - DepoMed: metformin, metformin gastric retention, metformin GR. Drugs RD, 5, 231-233.
18. Chow S.C., Liu J.P. (1992): Design and analysis of bioavailability and bioequivalence studies. New York: Marcel Dekker, Inc.
19. FDA. (1992): FDA Guidelines. Rockville, MD: Bioequivalence Food and Drug Administration, Division of Bioequivalence, Office of Generic Drugs, 1 July.