Limited sampling strategy to estimate pharmacokinetic parameters of orally administered metformin hydrochloride.
- Author:
Li-fang CHEN
1
;
Jian-jie JIAO
;
Cai-li ZHANG
;
Jian-shi LOU
;
Chang-xiao LIU
Author Information
1. Tianjin Haihe Hospital, Tianjin 300350, China.
- Publication Type:Journal Article
- MeSH:
Adult;
Area Under Curve;
Chromatography, High Pressure Liquid;
methods;
Humans;
Hypoglycemic Agents;
administration & dosage;
pharmacokinetics;
Linear Models;
Male;
Metformin;
administration & dosage;
pharmacokinetics;
Sample Size;
Therapeutic Equivalency;
Young Adult
- From:
Acta Pharmaceutica Sinica
2010;45(12):1533-1536
- CountryChina
- Language:Chinese
-
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.
