Pharmacokinetics and dose proportionality of extended-release metformin following administration of 1000, 1500, 2000 and 2500 mg in healthy volunteers.
Biopharm Drug Dispos
; 25(6): 261-3, 2004 Sep.
Article
en En
| MEDLINE
| ID: mdl-15334625
ABSTRACT
The pharmacokinetics and dose-exposure relationship of an extended-release formulation of metformin (ER-metformin) was investigated in a randomized, single-dose, four-period crossover study in 24 healthy male volunteers. During each study period, subjects received a randomly assigned dose containing 1000, 1500, 2000 or 2500 mg metformin. Blood samples were drawn 0-72 h after dosing for pharmacokinetic and dose-proportionality assessment. Although several pairwise comparisons between dose groups were significant (p<0.05) with respect to dose-normalized C(max), AUC(0-72 h), and AUC( infinity ), the magnitude of the difference across the dose range was <20% for AUC(0-72 h) and AUC( infinity ), and was < or = 30% for C(max). The results indicate a consistent and predictable increase in metformin exposure with an extended-release formulation of metformin over 1000 to 2500 mg.
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Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Hipoglucemiantes
/
Metformina
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Límite:
Humans
/
Male
Idioma:
En
Revista:
Biopharm Drug Dispos
Año:
2004
Tipo del documento:
Article
País de afiliación:
Estados Unidos