Journal of Diabetes and Metabolic Disorders 2006. 6(0):3-.

PHARMACOKINETIC AND PHARCODYNAMIC EVALUATION OF METFORMIN HCL 500 MG TABLET AMONG HEALTHY VOLUNTEERS.
Mohammad-Reza Rouini, Sima Sadray, Yalda H. Ardakani, Maryam Mokhberi, Solmaz Sedaghat

Abstract


Background: Metformin is used in treatment of non-insulin-dependent diabetes mellitus (NIDDM). The present study was aimed to study the pharmacokinetic and pharmaco-dynamic of metformin 500 mg tablet in healthy volunteers.


Methods: The test and reference metformin hydrochloride 500 mg tablets were administered to 12 healthy volunteers in a cross-over study. Metformin serum concentration and decrease in blood sugar levels (dBSL) were used for study of pharmacokinetic and pharmacodynamic.


Results: There was no correlation between phramacodynamic and pharmacokinetic para-meters. Also there was no increase in dBSL-(AUC0-12) with increase metformin serum concentration-time. The results of our study show that both products could be bioequivalent according to serum concentration and not blood sugar data.


Conclusion: There was no concentration - effect (dBSL) correlation for both products. Metformin didn't decrease the blood glucose in healthy volunteers. In some volunteers there was no increase in blood sugar after meal and dextrose 20% oral solution administration which could be related to decreased absorption of glucose from gastrointestinal tract caused by metformin.


Keywords


Metformin, Pharmacokinetic, Pharmacodynamic, Serum concentration, Blood sugar,

Refbacks

  • There are currently no refbacks.