【摘 要】
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Background: Tenofovir disoproxil fumarate has been approved worldwide for the treatment of Chronic Hepatitis B in adults and treatment of HIV-1 infection in combination with other antiretroviral agent
【机 构】
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Phase Ⅰ Clinical Research Unit, Shanghai Xuhui Central Hospital 20F Building No.1,966 Middle Huaihai
【出 处】
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中国药理学会药物临床试验专业委员会首届学术研讨会
论文部分内容阅读
Background: Tenofovir disoproxil fumarate has been approved worldwide for the treatment of Chronic Hepatitis B in adults and treatment of HIV-1 infection in combination with other antiretroviral agents for several years.Its also approved for treatment of HIV by the Chinese State Food and Drug Administration, but there are no data about the pharmacokinetic profile of Tenofovir disoproxil fumarate in Chinese individuals.Objectives: To investigate the pharmacokinetics, safety and tolerability of tenofovir disoproxil fumarate in healthy Chinese subjects.Method: This was an open-label, single group, single and multiple dose study in fourteen healthy Chinese subjects.All the subjects received a single dose and 7 days repeat dosing with tenofovir disoproxil fumarate 300 mg once daily.Multiple plasma samples over time were collected and the concentrations oftenofovir were determined by a liquid chromatography-tandem mass spectrometric method.Pharmacokinetic parameters were estimated using non-compartmental model.Safety and tolerability were determined by clinical evaluation and monitoring of adverse events.Results: Tenofovir disoproxil fumarate was rapidly absorbed, median tenofovivr Tmax was 0.75 hour and a t1/2 of approximately 21 hours.The pharmacokinetics of tenofovir were consistent between single dose and multiple dose, and it was similar between males and females.There were no serious adverse events reported and no discontinuations due to adverse events.Conclusions: Tenofovir disoproxil fumarate was generally well tolerated by healthy Chinese subjects and exhibits a similar pharmacokinetic profile with healthy Western subjects.
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