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2009•The Journal of Medical Theory and PracticeRequires access

Pharmacokinetic and Bioequivalence of Ibuprofen Soft Capsules in Healthy Volunteers

Hou Yannin

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Abstract

Objective:To study pharmacokinetics of ibuprofen soft capsules in healthy human subjects and its bioequivalence.Methods:In a randomized crossover study,18 healthy male volunteers were given a single oral dose of 400mg ibuprofen.The concentration of ibuprofen in plasma was determined by HPLC.The pharmacokinetic parameters were processed by DAS program for statistic analysis.Results:The pharmacokinetic parameters of the test and reference preparations were as follows:cmax were (50.45±7.08)and (45.18±8.01)μg·ml-1; tmax were(0.48±0.21)and(0.68±0.31)h;AUC0-10h were (135.26±20.9)and (140.26±21.72)μg·ml-1·h-1;AUC0-∞ were (139.85±21.45) and (145.46±23.93)μg·ml-1·h-1;t1/2 were (2.06±0.26) and (2.04±0.25) h,respectively.The relative bioavailability of the test preparations was (96.98±10.52).Conclusion:The two preparations were bioequivalent.

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What this paper is about

Objective:To study pharmacokinetics of ibuprofen soft capsules in healthy human subjects and its bioequivalence.Methods:In a randomized crossover study,18 healthy male volunteers were given a single oral dose of 400mg ibuprofen.The concentration of ibuprofen in plasma was determined by HPLC.The pharmacokinetic parameters were processed by DAS program for statistic analysis.Results:The pharmacokinetic parameters of the test and reference preparations were as follows:cmax were (50.45±7.08)and (45.18±8.01)μg·ml-1; tmax were(0.48±0.21)and(0.68±0.31)h;AUC0-10h were (135.26±20.9)and (140.26±21.72)μg·ml-1·h-1;AUC0-∞ were (139.85±21.45) and (145.46±23.93)μg·ml-1·h-1;t1/2 were (2.06±0.26) and (2.04±0.25) h,respectively.The relative bioavailability of the test preparations was (96.98±10.52).Conclusion:The two preparations were bioequivalent.

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Available abstract

Objective:To study pharmacokinetics of ibuprofen soft capsules in healthy human subjects and its bioequivalence.Methods:In a randomized crossover study,18 healthy male volunteers were given a single oral dose of 400mg ibuprofen.The concentration of ibuprofen in plasma was determined by HPLC.The pharmacokinetic parameters were processed by DAS program for statistic analysis.Results:The pharmacokinetic parameters of the test and reference preparations were as follows:cmax were (50.45±7.08)and (45.18±8.01)μg·ml-1; tmax were(0.48±0.21)and(0.68±0.31)h;AUC0-10h were (135.26±20.9)and (140.26±21.72)μg·ml-1·h-1;AUC0-∞ were (139.85±21.45) and (145.46±23.93)μg·ml-1·h-1;t1/2 were (2.06±0.26) and (2.04±0.25) h,respectively.The relative bioavailability of the test preparations was (96.98±10.52).Conclusion:The two preparations were bioequivalent.

Key concepts: Bioequivalence, Medicine, Pharmacokinetics, Ibuprofen, Bioavailability, Cmax, Crossover study, Pharmacology

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