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2013•The Chinese Journal of Clinical PharmacologyRequires access

Bioequivalence of metformin in healthy volunteers by HPLC-MS/MS

Liu Ze-yuan

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Abstract

Objective To evaluate the bioequivalence of metformin in healthy volunteers.Methods A dual-cycle,randomized,crossover trial design on 24 healthy male volunteers was carried out with orally test drug and reference drug(500 mg).Each time has an interval of 7 days.Plasma samples were calculated HPLC-MS/MS.The pharmacokinetic parameters of test and reference formulation were calculated with Phoenix WinNonlin 6.1 software.Results The main pharmacokinetic parameters of metformin test and reference preparations as follows: Cmax were(1356.29±403.36),(1408.96±395.54)μg·L-1,tmax were(2.13±1.13),(2.33±1.01)h,t1/2 were(6.95±3.03),(6.53±1.40)h,AUC0-tn were(8141.90±1715.27),(8789.72±2028.34)μg·h·L-1,Fn-tn of test preparation were(98.31±14.07)%,Cmax and AUC0-tn 90% confidence interval were 83.13%-101.45%,87.41%-102.59%.Conclusion The test tablets are bioequivalent to the reference tablets.

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What this paper is about

Objective To evaluate the bioequivalence of metformin in healthy volunteers.Methods A dual-cycle,randomized,crossover trial design on 24 healthy male volunteers was carried out with orally test drug and reference drug(500 mg).Each time has an interval of 7 days.Plasma samples were calculated HPLC-MS/MS.The pharmacokinetic parameters of test and reference formulation were calculated with Phoenix WinNonlin 6.1 software.Results The main pharmacokinetic parameters of metformin test and reference preparations as follows: Cmax were(1356.29±403.36),(1408.96±395.54)μg·L-1,tmax were(2.13±1.13),(2.33±1.01)h,t1/2 were(6.95±3.03),(6.53±1.40)h,AUC0-tn were(8141.90±1715.27),(8789.72±2028.34)μg·h·L-1,Fn-tn of test preparation were(98.31±14.07)%,Cmax and AUC0-tn 90% confidence interval were 83.13%-101.45%,87.41%-102.59%.Conclusion The test tablets are bioequivalent to the reference tablets.

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Available abstract

Objective To evaluate the bioequivalence of metformin in healthy volunteers.Methods A dual-cycle,randomized,crossover trial design on 24 healthy male volunteers was carried out with orally test drug and reference drug(500 mg).Each time has an interval of 7 days.Plasma samples were calculated HPLC-MS/MS.The pharmacokinetic parameters of test and reference formulation were calculated with Phoenix WinNonlin 6.1 software.Results The main pharmacokinetic parameters of metformin test and reference preparations as follows: Cmax were(1356.29±403.36),(1408.96±395.54)μg·L-1,tmax were(2.13±1.13),(2.33±1.01)h,t1/2 were(6.95±3.03),(6.53±1.40)h,AUC0-tn were(8141.90±1715.27),(8789.72±2028.34)μg·h·L-1,Fn-tn of test preparation were(98.31±14.07)%,Cmax and AUC0-tn 90% confidence interval were 83.13%-101.45%,87.41%-102.59%.Conclusion The test tablets are bioequivalent to the reference tablets.

Key concepts: Bioequivalence, Cmax, Pharmacokinetics, Confidence interval, Crossover study, Metformin, Pharmacology, Medicine

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