Pharmacokinetics, Food Effect, Ketoconazole Interaction, and Safety of JTK-853, a Novel Nonnucleoside HCV Polymerase Inhibitor, After Ascending Single and Multiple Doses in Healthy Subjects [0.03%]
JTK-853（一种新型非核糖体HCV聚合酶抑制剂）在健康志愿者中的药代动力学、食物影响及酮康唑相互作用和安全性：单次给药和多次递增剂量试验
Sekihiro Tamaki,Tsutomu Shibata,Thomas Hunt et al.
Sekihiro Tamaki et al.
Pharmacokinetics, safety, and tolerability of JTK-853, a novel HCV polymerase inhibitor, were evaluated in single and multiple ascending dose (SAD, MAD) studies, with food- and ketoconazole-related effects on exposure to JTK-853 and its act...
The Relative Bioavailability and Effects of Food and Acid-Reducing Agents on Filgotinib Tablets in Healthy Subjects [0.03%]
健康受试者中filgotinib片剂的相对生物利用度及食物和抑酸药的影响
Kacey Anderson,Hao Zheng,Mona Kotecha et al.
Kacey Anderson et al.
Filgotinib is a potent, selective Janus kinase-1 inhibitor being developed to treat chronic inflammatory diseases. This phase 1 study in healthy subjects evaluated the relative bioavailability of filgotinib maleate tablets versus the refere...
Lesinurad: Evaluation of Pharmacokinetic and Pharmacodynamic Interactions With Warfarin in Healthy Volunteers [0.03%]
lesinurad：与华法林在健康受试者中的药代动力学和药效学相互作用的评价
Zancong Shen,Caroline A Lee,Kathleen Wallach et al.
Zancong Shen et al.
Lesinurad is a selective uric acid reabsorption inhibitor approved for use in combination with xanthine oxidase inhibitors for the treatment of hyperuricemia associated with gout. In vitro, lesinurad was shown to be a weak inhibitor of cyto...
Effects of Food and Antacids on Pharmacokinetics and Pharmacodynamics of Lesinurad, a Selective Urate Reabsorption Inhibitor [0.03%]
食物和抗酸药对选择性尿酸重吸收抑制剂lesinurad的药代动力学和药效学的影响
Zancong Shen,Caroline A Lee,Shakti Valdez et al.
Zancong Shen et al.
Two clinical studies were performed in healthy volunteers to investigate food and antacid effects on lesinurad, a novel selective uric acid reabsorption inhibitor approved for treatment of hyperuricemia associated with gout in combination w...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2019 Jul;8(5):647-656. DOI:10.1002/cpdd.663 2019
A Cocktail Interaction Study Evaluating the Drug-Drug Interaction Potential of the Perpetrator Drug ASP8477 at Multiple Ascending Dose Levels [0.03%]
一项关于施害药物ASP8477多个递增剂量水平的鸡尾酒式相互作用研究以评估其潜在的药物-药物相互作用风险的研究报告
Nicoline Treijtel,Christiane Collins,Michel van Bruijnsvoort et al.
Nicoline Treijtel et al.
ASP8477 (molecular weight 325.36 g/mol) is a fatty acid amide hydrolase inhibitor intended for the treatment of neuropathic pain. Results from in vitro studies indicated that ASP8477 is a direct inhibitor of cytochrome P450 (CYP) 2C8, 2C9, ...
Designer Benzodiazepines: A Review of Published Data and Public Health Significance [0.03%]
苯二氮卓类新精神活性物质研究进展及其公共卫生意义
H Karl Greenblatt,David J Greenblatt
H Karl Greenblatt
Randomized Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Topical Daprodustat in Healthy Volunteers and in Patients With Diabetic Foot Ulcers [0.03%]
达普罗 dustat 的随机一期试验：健康受试者和糖尿病足溃疡患者的耐受性，药代动力学和药效学的评估
Eric Olson,Kelly M Mahar,Lisa Morgan et al.
Eric Olson et al.
Daprodustat, a small-molecule inhibitor of prolyl hydroxylases, prevents breakdown of hypoxia-inducible factor (HIF), leading to increased transcription of HIF-responsive genes. This randomized, placebo-controlled study evaluated the safety...
Use of Population Pharmacokinetic Analyses Among FDA-Approved Biologics [0.03%]
美国FDA批准的生物制剂人群药代动力学分析应用情况回顾
Ken Ogasawara,G Caleb Alexander
Ken Ogasawara
Biologics, especially monoclonal antibodies, are increasingly important in the pharmaceutical marketplace. Population pharmacokinetic (PK) analyses could be useful to guide the need for dose adjustments among special populations, yet it is ...
Influence of Renal Function on Evolocumab Exposure, Pharmacodynamics, and Safety [0.03%]
肾功能对Evolocumabe暴露量、药理动力学和安全性的影响
Edward Lee,John P Gibbs,Maurice G Emery et al.
Edward Lee et al.
We evaluated the pharmacokinetics, pharmacodynamics, and safety of evolocumab, a fully human monoclonal antibody against proprotein convertase subtilisin kexin type 9 (PCSK9), in an open-label, parallel-design study in participants with nor...
Exposure-Response Analysis for Efficacy of Daclatasvir, Asunaprevir, and Beclabuvir Combinations in HCV-Infected Patients [0.03%]
用于HCV感染者达克立松、阿舒瑞韦和贝拉米芬联合治疗的量效关系分析
T Ueno,M Osawa,T Shiozaki et al.
T Ueno et al.
The combination regimen of daclatasvir, asunaprevir, and beclabuvir (3DAA regimen) was developed as a fixed-dose combination for the treatment of hepatitis C virus (HCV) infection in Japan. The objectives of this analysis were to characteri...