Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER)

NCT ID: NCT00941239


Title
Gastric Tolerability and Pharmacokinetics of an Extended Release Metformin and an Immediate Release Metformin
Purpose
The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of an extended release metformin compared with an immediate release metformin in healthy subjects.
Details
Conditions
Healthy
Keywords
Metformin ER, Pharmacokinetics, Tolerability, Healthy volunteers
Source
Laboratorios Silanes S.A. de C.V.
Sponsors
Laboratorios Silanes S.A. de C.V.
Status
Completed
Acronym
Last Updated
21 Oct 2015
URL
Official Link
Citations/Publications
Blonde L, Dailey GE, Jabbour SA, Reasner CA, Mills DJ. Gastrointestinal tolerability of extended-release metformin tablets compared to immediate-release metformin tablets: results of a retrospective cohort study. Curr Med Res Opin. 2004 Apr;20(4):565-72.

Hale TW, Kristensen JH, Hackett LP, Kohan R, Ilett KF. Transfer of metformin into human milk. Diabetologia. 2002 Nov;45(11):1509-14.

Stumvoll M, Nurjhan N, Perriello G, Dailey G, Gerich JE. Metabolic effects of metformin in non-insulin-dependent diabetes mellitus. N Engl J Med. 1995 Aug 31;333(9):550-4.

Brown BW Jr. The crossover experiment for clinical trials. Biometrics. 1980 Mar;36(1):69-79.

Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80.

Westlake WJ. Symmetrical confidence intervals for bioequivalence trials. Biometrics. 1976 Dec;32(4):741-4.

The United States Pharmacopeia USP26. Pags 525-526. 2003. Rockville. MD.

Locations
Mexico