Limited sampling strategy to estimate pharmacokinetic parameters of orally administered metformin hydrochloride / 药学学报
Acta Pharmaceutica Sinica
;
(12): 1533-1536, 2010.
Artigo
em Chinês
| WPRIM
| ID: wpr-250600
ABSTRACT
The present study was to estimate pharmacokinetic parameters of metformin hydrochloride in 20 Chinese healthy volunteers with a limited sampling strategy (LSS), which will provide scientific data for bioequivalence and clinical application. A single dose of metformin was administrated to 20 healthy volunteers. The concentration of metformin in whole blood was determined by validated high performance liquid chromatography (HPLC) method. Multi-linear regression analysis was performed to establish a model to estimate AUC(0-24 h) and Cmax of metformin by LSS method. The LSS models were validated by the Jackknife method. The result indicated the linearity relationship between AUC(0-24 h) or Cmax and single concentration point was poor. Several models for metformin AUC(0-24 h) or Cmax, estimation were better (r2 > 0.9, P < 0.05). Validation tests indicated that most informative sampling points (C2, C6 for AUC(0-24 h), C1.5, C2 for Cmax) provided accurate estimations of these parameters. So, a multi-linear regression model for estimation pharmacokinetic parameters of metformin by using LSS method is feasible.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Farmacocinética
/
Equivalência Terapêutica
/
Modelos Lineares
/
Cromatografia Líquida de Alta Pressão
/
Tamanho da Amostra
/
Área Sob a Curva
/
Hipoglicemiantes
/
Metformina
/
Métodos
Tipo de estudo:
Estudo prognóstico
Limite:
Adulto
/
Humanos
/
Masculino
Idioma:
Chinês
Revista:
Acta Pharmaceutica Sinica
Ano de publicação:
2010
Tipo de documento:
Artigo
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