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KMID : 0370220070510060440
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Yakhak Hoeji
2007 Volume.51 No. 6 p.440 ~ p.446
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Methods for Pharmacodynamic Analysis and Proposed Protocols for Bioequivalence Study of Acarbose
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Bae Jung-Woo
Jang Choon-Gon
Lee Seok-Yong
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Abstract
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Arcabose is a competitive inhibitor of the intestinal {alpha}-glucosidases and reduces the postprandial digestion and absorption of carbohydrate and disaccharides. Due to its negligible oral absorption, measuring drug concentration in the plasma is impractical. Thus, the common pharmacokinetic study is not available to determine the bioequivalence of the generic acarbose preparations. The aim of this study is the establishment of pharmacodynamic assessment method for the bioequivalence test of the generic acarbose preparations. Placebo-controlled cross-over (3{times}3) clinical study was conducted in 23 healthy volunteers. Volunteers received a single oral dose of placebo, reference drug (Glucoby^{(R)} 100 mg, Lot # D043) or test drug (Glucoby^{(R)} 100 mg, Lot # E005) just before breakfast, then blood samples for evaluation of serum glucose and insulin levels were taken during for 4 hours. C_{max},;AUC_{0-2},;AUC_{0-4},;{Delta}C_{max},;{Delta}AUC_{0-2};and;{Delta}AUC_{0-4} of the postprandial plasma glucose level significantly decreased when a single dose of acarbose 100 mg preparations was administered. However, any significant difference was not detected between the groups taken the reference drug and the test drug. These results proposed that the pharmacodynamic protocols of this study is suitable to use for bioequivalence test of acarbose preparations. On the basis of the results of this study and the data of literature on this subject, the standard protocols of bioequivalence study of acarbose preparation are proposed.
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KEYWORD
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acarbose, postprandial glucose, pharmacodynamics, bioequivalence
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