2010•Zhongguo linchuang yaolixue yu zhiliaoxueRequires access

Pharmacokinetics of Huperzine A substain-release tablets after multiple doses in healthy volunteers

Chunjie Sha

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Abstract

AIM:To evaluate the pharmacokinetics of Huperzine A sustained-release tablets after multiple doses in Chinese healthy volunteers.METHODS:In a randomized crossover trial,24 healthy subjects received multiple oral doses of either Huperzine A sustained-release tablets or a common Huperzine A tablet for 7 days.The plasma concentrations were determined by LC/MS/MS.Pharmacokinetic parameters were obtained using DAS program.RESULTS:The major pharmacokinetic parameters of test and reference Huperzine A tables were as follows:Css min were (0.54±0.21) and (0.79±0.20)ng/mL,Css max were (1.65±0.45)and (1.83±0.37)ng/mL,Css were (1.05±0.28) and (1.22±0.28)ng/mL,tmax were (3.5±1.9) and (1.1±0.4) h,AUC0-t(ss) were (31±8) and (35±9)ng·mL-1·h,AUC0-∞(ss) were (37±10)and (41±11)ng·mL-1·h,AUCss were (25±7)and (15±3)ng·mL-1·h,respectively.The relative bioavailability of test tablet as estimated by AUC0-t(ss) was (88±12) %.There was significant difference in tmax between two tablets.CONCLUSION:The results show that the Huperzine A substain-release tablets clearly have the characteristic of slow releasing properties.

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AIM:To evaluate the pharmacokinetics of Huperzine A sustained-release tablets after multiple doses in Chinese healthy volunteers.METHODS:In a randomized crossover trial,24 healthy subjects received multiple oral doses of either Huperzine A sustained-release tablets or a common Huperzine A tablet for 7 days.The plasma concentrations were determined by LC/MS/MS.Pharmacokinetic parameters were obtained using DAS program.RESULTS:The major pharmacokinetic parameters of test and reference Huperzine A tables were as follows:Css min were (0.54±0.21) and (0.79±0.20)ng/mL,Css max were (1.65±0.45)and (1.83±0.37)ng/mL,Css were (1.05±0.28) and (1.22±0.28)ng/mL,tmax were (3.5±1.9) and (1.1±0.4) h,AUC0-t(ss) were (31±8) and (35±9)ng·mL-1·h,AUC0-∞(ss) were (37±10)and (41±11)ng·mL-1·h,AUCss were (25±7)and (15±3)ng·mL-1·h,respectively.The relative bioavailability of test tablet as estimated by AUC0-t(ss) was (88±12) %.There was significant difference in tmax between two tablets.CONCLUSION:The results show that the Huperzine A substain-release tablets clearly have the characteristic of slow releasing properties.

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Available abstract

AIM:To evaluate the pharmacokinetics of Huperzine A sustained-release tablets after multiple doses in Chinese healthy volunteers.METHODS:In a randomized crossover trial,24 healthy subjects received multiple oral doses of either Huperzine A sustained-release tablets or a common Huperzine A tablet for 7 days.The plasma concentrations were determined by LC/MS/MS.Pharmacokinetic parameters were obtained using DAS program.RESULTS:The major pharmacokinetic parameters of test and reference Huperzine A tables were as follows:Css min were (0.54±0.21) and (0.79±0.20)ng/mL,Css max were (1.65±0.45)and (1.83±0.37)ng/mL,Css were (1.05±0.28) and (1.22±0.28)ng/mL,tmax were (3.5±1.9) and (1.1±0.4) h,AUC0-t(ss) were (31±8) and (35±9)ng·mL-1·h,AUC0-∞(ss) were (37±10)and (41±11)ng·mL-1·h,AUCss were (25±7)and (15±3)ng·mL-1·h,respectively.The relative bioavailability of test tablet as estimated by AUC0-t(ss) was (88±12) %.There was significant difference in tmax between two tablets.CONCLUSION:The results show that the Huperzine A substain-release tablets clearly have the characteristic of slow releasing properties.

Key concepts: Huperzine A, Pharmacokinetics, Bioavailability, Bioequivalence, Crossover study, Pharmacology, Medicine, Chemistry

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