Pharmacokinetics and tolerability of tenofovir disoproxil fumarate in healthy Chinese subjects

来源 :中国药理学会药物临床试验专业委员会首届学术研讨会 | 被引量 : 0次 | 上传用户:xutao6310794
下载到本地 , 更方便阅读
声明 : 本文档内容版权归属内容提供方 , 如果您对本文有版权争议 , 可与客服联系进行内容授权或下架
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.
其他文献
目的:建立实验用大鼠子宫内膜异位症模型,评价诺美孕酮对大鼠子宫内膜异位症的治疗作用并初步探讨作用机理.方法:手术法建立大鼠子宫内膜异位症模型.以孕三烯酮为阳性对照,同时设模型对照组和空白对照组.造模成功大鼠分别灌胃给予低(0.5mg/kg)、中(1.5mg/kg)、和高(15mg/kg)3个不同剂量诺美孕酮,连续21天,观察大鼠的体重变化、异位内膜生长体积、主要肝功能生化指标及凋亡相关指标的影响.
目的:评价Adjudin对人精子的受精能力及其可能的作用机制.方法:根据WHO(1999)男性学标准,从浙江省精子库获得45例生育男子精液标本.精子获能和顶体反应评价采用CTC免疫荧光染色法;以人精子穿透去透明带仓鼠卵(SPA)鉴定人精子的受精能力;精子活力及其超激活运动(HAM)鉴定采用CASA分析方法;以EIA法测定精子细胞cAMP水平;采用PY、PS和PT抗体免疫测定评价Adjudin是否参
Objective To investigate the clinical and characteristics, diagnosis, treatment and prognosis of minimal deviation adenocarcinoma of the cervix.Methods 13 cases of cervical minimal deviation adenocarc
目的:通过度他雄胺对大鼠附睾上皮细胞连接关键蛋白claudinl和β-catenin表达影响的研究,探讨度他雄胺抑制生育可能的分子机制,为男性不育治疗和男性避孕提供附睾靶点.方法:设度他雄胺40mg/kg灌胃组和阴性对照组,每组8只,灌胃给药,1次/天,连续2周.给药结束后CASA评价雄鼠精子活力形态,交配雌鼠受孕率,对附睾进行分离称重,剪切成三部分(头部、体部和尾部),透射电镜分析附睾起始、头、
目的:通过构建子宫内膜异位症的体外模型,研究人参皂苷Rh2对实验性子宫内膜异位症的治疗作用,并探讨人参皂苷Rh2对子宫内膜异位症的作用机制.方法:子宫内模异位症患者的异位内膜组织经Ⅱ胶原酶消化后,过筛后人子宫异位内膜细胞进行体外培养,建立人子宫内膜异位症的体外细胞模型.用无酚红DMEM/F12培养液(含10%活性炭吸附FBS)培养人子宫异位内膜细胞,用不同浓度的Rh2(0.0001~100μmol
淫羊藿为小檗科植物淫羊藿、箭叶淫羊藿、柔毛淫羊藿、或朝鲜淫羊藿的干燥叶,具有补肾阳,强筋骨,祛风湿等功效,有效成分为淫羊藿苷及其肠道代谢产物淫羊藿次苷、淫羊藿素等.当今,许多国家使用淫羊藿或其提取物来治疗男性性功能障碍问题并取得良好的疗效,但关于淫羊藿苷及其代谢产物与其它药物间相互作用的研究却很少.本文对淫羊藿苷及其肠道代谢产物在人肠道UGT酶作用下发生药物-药物相互作用的潜在可能性进行了研究.通
目的:研究健康受试者单剂量静脉注射海姆泊芬后的药代动力学的性别差异、物料平衡及给药后光毒性反应。方法:16名健康受试者,男女各半,剂量5mg·kg-1,分2批进行试验,每批8名,仅在第2批受试者中进行粪样采集,第2批受试者光毒试验的方法根据第1批受试者的光毒试验结果进行调整。采用经验证过的LC-MS/MS法测定血浆、尿液和粪便中海姆泊芬及其代谢产物血卟啉的含量。药代动力学参数采用WinNonlin
目的:提出一种流速调节方法实现体外一室药动学模型对体内口服给药药动学(PK)的精确模拟.方法:根据体内药物浓度随时间的相对变化率与体外相等的原则,采用公式法推导流速调节公式.由体外剂量与体内剂量之比等于体外中央室液体容积与体内中央室分布容积之比得到吸收室投药量,吸收室液体容积根据一房室模型计算式进行设计.从理论角度证明体外一室药动学模型可精确模拟体内线性乳突模型、零级模型以及非线性药动学模型,并用
Background: Benvitimod is a newly synthesized non-steroidal small molecule, which is aimed at the treatment of psoriasis.Several trials have demonstrated that benvitimod improves plaque psoriasis.Howe
Purpose: In this study, we want to investigate the correlations between UbcH10 expression and clinical pathological characteristics and survival time of NSCLC patients.In addition, the expression of U