title: [Limited sampling strategy to estimate pharmacokinetic parameters of orally administered metformin hydrochloride].
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.
authors.affiliation: Tianjin Haihe Hospital, Tianjin 300350, China.
authors.forename: Li-fang
authors.initials: LF
authors.lastname: Chen
authors.forename: Jian-jie
authors.initials: JJ
authors.lastname: Jiao
authors.forename: Cai-li
authors.initials: CL
authors.lastname: Zhang
authors.forename: Jian-shi
authors.initials: JS
authors.lastname: Lou
authors.forename: Chang-xiao
authors.initials: CX
authors.lastname: Liu
mesh_terms: D000328:Adult; D019540:Area Under Curve; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D016014:Linear Models; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D018401:Sample Size; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D007004:Hypoglycemic Agents; D008687:Metformin