Limited sampling strategy to estimate pharmacokinetic parameters of orally administered metformin hydrochloride / 药学学报
Acta Pharmaceutica Sinica
;
(12): 1533-1536, 2010.
Article
in Chinese
| 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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Pharmacokinetics
/
Therapeutic Equivalency
/
Linear Models
/
Chromatography, High Pressure Liquid
/
Sample Size
/
Area Under Curve
/
Hypoglycemic Agents
/
Metformin
/
Methods
Type of study:
Prognostic study
Limits:
Adult
/
Humans
/
Male
Language:
Chinese
Journal:
Acta Pharmaceutica Sinica
Year:
2010
Type:
Article
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