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RELATIVE BIOAVAILABILITY OF TWO DOMESTIC GELICLAZID TABLETS IN HUMAN

Zhi Zhang

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Abstract

OBJECTIVE:To study the pharmacokinetic and relative bioavailability of two domestic Geliclazid tablets in 18 volunteers following a single oral dose of 80 mg.METHODS:The formulatinos of Geliclazid tablets(A and B)were given respectively to 18 volunteers in a open randomized cross over test.The Geliclazid concentrations in serum were determined by RP HPLC.RESULTS:The AUC 0→∞ 、T max ,C max of Geliclazid tablets A and B were (81.57±30.26)μg.h·ml -1 and (80.31±29.42)μg.h·ml -1 ,(4.64±0.29)h and (4.58±0.26)h,(5.77±1.77)μg·ml -1 and (5.73±1.91)μg·ml -1 .CONCLUSION: The statistics analysis showed that there were no significant difference between the two formulations in AUC 0→∞ ,T max ,C max ,the two formulations were bioequivalent.

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What this paper is about

OBJECTIVE:To study the pharmacokinetic and relative bioavailability of two domestic Geliclazid tablets in 18 volunteers following a single oral dose of 80 mg.METHODS:The formulatinos of Geliclazid tablets(A and B)were given respectively to 18 volunteers in a open randomized cross over test.The Geliclazid concentrations in serum were determined by RP HPLC.RESULTS:The AUC 0→∞ 、T max ,C max of Geliclazid tablets A and B were (81.57±30.26)μg.h·ml -1 and (80.31±29.42)μg.h·ml -1 ,(4.64±0.29)h and (4.58±0.26)h,(5.77±1.77)μg·ml -1 and (5.73±1.91)μg·ml -1 .CONCLUSION: The statistics analysis showed that there were no significant difference between the two formulations in AUC 0→∞ ,T max ,C max ,the two formulations were bioequivalent.

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Available abstract

OBJECTIVE:To study the pharmacokinetic and relative bioavailability of two domestic Geliclazid tablets in 18 volunteers following a single oral dose of 80 mg.METHODS:The formulatinos of Geliclazid tablets(A and B)were given respectively to 18 volunteers in a open randomized cross over test.The Geliclazid concentrations in serum were determined by RP HPLC.RESULTS:The AUC 0→∞ 、T max ,C max of Geliclazid tablets A and B were (81.57±30.26)μg.h·ml -1 and (80.31±29.42)μg.h·ml -1 ,(4.64±0.29)h and (4.58±0.26)h,(5.77±1.77)μg·ml -1 and (5.73±1.91)μg·ml -1 .CONCLUSION: The statistics analysis showed that there were no significant difference between the two formulations in AUC 0→∞ ,T max ,C max ,the two formulations were bioequivalent.

Key concepts: Bioequivalence, Bioavailability, Pharmacokinetics, Chromatography, Chemistry, High-performance liquid chromatography, Significant difference, Pharmacology

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