Volume 6, Issue 2 (18 2006)
ijdld 2006, 6(2): 135-141 |
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PHARMACOKINETIC AND PHARCODYNAMIC EVALUATION OF METFORMIN HCL 500 MG TABLET AMONG HEALTHY VOLUNTEERS
Abstract: (9121 Views)
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.
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.
Type of Study: Research |
Subject:
General
Received: 2006/12/11 | Accepted: 2007/03/9 | Published: 2013/10/14
Received: 2006/12/11 | Accepted: 2007/03/9 | Published: 2013/10/14
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