title: Effect of voglibose on the pharmacokinetics of metformin in healthy Korean subjects.
abstract: OBJECTIVE
  The objective of this study was to evaluate the effects of voglibose on the pharmacokinetics of metformin.
  
  
  METHODS
  A randomized, open-label, two-way crossover study with a 7-day washout period was conducted. All subjects were given an oral dose of metformin with or without voglibose 3 x daily for 7 days. Plasma concentrations of metformin on day 7 were measured using high performance liquid chromatography (HPLC) with UV detection for pharmacokinetic assessment Vital signs and adverse events were monitored, and physical examinations and laboratory tests were conducted to evaluate safety.
  
  
  RESULTS
  22 subjects completed the study. The geometric mean ratios for C(ss,max) of metformin (metformin plus voglibose vs. metformin only) were 0.98 (90% CI, 0.92 - 1.05; p > 0.05) and for AUC-τ, the ratio was 0.99 (90% CI, 0.92 - 1.06; p > 0.05). There were no significant differences in adverse drug reactions between metformin with and without voglibose. However, the incidence of adverse events was higher in period 1 than in period 2 (16 cases vs. 1 case, p < 0.001).
  
  
  CONCLUSIONS
  Co-administration of metformin and voglibose had no statistically or clinically significant effects on the pharmacokinetics of metformin in healthy subjects. The pharmacodynamic interaction study to evaluate the effect of metformin on the pharmacodynamics of voglibose is in progress.
authors.forename: Ho-Sook
authors.initials: HS
authors.lastname: Kim
authors.forename: Minkyung
authors.initials: M
authors.lastname: Oh
authors.forename: Eun Ji
authors.initials: EJ
authors.lastname: Kim
authors.forename: Geun Seog
authors.initials: GS
authors.lastname: Song
authors.forename: Jong-Lyul
authors.initials: JL
authors.lastname: Ghim
authors.forename: Ji-Hong
authors.initials: JH
authors.lastname: Shon
authors.forename: Dong-Hyun
authors.initials: DH
authors.lastname: Kim
authors.forename: Jae-Gook
authors.initials: JG
authors.lastname: Shin
mesh_terms: D000328:Adult; D018592:Cross-Over Studies; D004347:Drug Interactions; D065089:Glycoside Hydrolase Inhibitors / Q000494:pharmacology*; D006801:Humans; D007004:Hypoglycemic Agents / Q000493:pharmacokinetics*; D007294:Inositol / Q000031:analogs & derivatives* / Q000494:pharmacology; D008297:Male; D008687:Metformin / Q000493:pharmacokinetics*; D008875:Middle Aged
chemical_list: D065089:Glycoside Hydrolase Inhibitors; D007004:Hypoglycemic Agents; D007294:Inositol; D008687:Metformin; C102817:voglibose