دوره 6، شماره 2 - ( 6-1385 )
جلد 6 شماره 2 صفحات 141-135 |
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Rouini M, Sadray S, H. Ardakani Y, Mokhberi M, Solmaz S. PHARMACOKINETIC AND PHARCODYNAMIC EVALUATION OF METFORMIN HCL 500 MG TABLET AMONG HEALTHY VOLUNTEERS. ijdld 2006; 6 (2) :135-141
URL: http://ijdld.tums.ac.ir/article-1-5070-fa.html
URL: http://ijdld.tums.ac.ir/article-1-5070-fa.html
روئینی محمد رضا، صدرای سیما، حسین زاده اردکانی یلدا، مخبری مریم، صداقت سولماز. ارزیابی فارماکوکینتیک و فارماکودینامیک قرص پانصد میلی گرمی متفورمین هیدروکلراید در داوطلبان سالم. مجله دیابت و متابولیسم ایران. 1385; 6 (2) :135-141
چکیده: (9123 مشاهده)
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.
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