Aims: Recently a limited sampling strategy (LSS) for determination of metformin' pharmacokinetics was developed. The LSS utilizes the plasma concentration of metformin 3 and 10 hours after oral intake of a single dose to estimate the area under the concentration-time curve up to 24 hours (AUC ). The main purpose of this study was to support the feasibility of this strategy in a large prospective trial.
Methods: Volunteers orally ingested two 500-mg tablets of metformin hydrochloride. A blood sample was drawn three and ten hours after the ingestion. Urine was collected for 0-10 and 10-24 hours and urine volumes recorded. The AUC was calculated using the equation AUC = 4.779 * C + 13.174 * C . Additionally, all participants were genotyped for the single-nucleotide polymorphism A270S in OCT2, g.-66 T > C in MATE1, R61C, G465R, G401S and the deletion M420del in OCT1.
Results: In total, 212 healthy volunteers participated. The median (25th - 75th interquartile range) AUC , CL , C and C , were 10 600 (8470-12 500) ng* hr* mL , 29 (24-34) L* hour , 1460 (1180-1770) and 260 (200-330) ng* mL , respectively, which is in agreement with our previous results. GFR was correlated with metformin AUC and CL (P < .001). As expected, we found a great pharmacokinetic interindividual variability among the volunteers and no effect of the OCT1 genotype on the AUC . We were unable to reproduce our previous finding of a gene-gene interaction (OCT2 and MATE1) effect on CL in this cohort.
Conclusion: This study further supports the use of the 2-point LSS algorithm in large pharmacokinetic trials.
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