A Study to Assess the Proarrhythmic Potential of Mirtazapine Using Concentration-QTc (C-QTc) Analysis [0.03%]
浓度-QT间期离散度分析评估米塔扎平致心律失常潜能的研究
Sevgi Gurkan,Fang Liu,Anne Chain et al.
Sevgi Gurkan et al.
Most new chemical entities with systemic availability are required to be tested in a study specifically designed to exclude drug-induced corrected QT interval (QTc) effects, the so-called thorough QT/QTc study. Mirtazapine (Remeron™) is an...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2019 May;8(4):449-458. DOI:10.1002/cpdd.605 2019
Amenamevir: Studies of Potential CYP3A-Mediated Pharmacokinetic Interactions With Midazolam, Cyclosporine, and Ritonavir in Healthy Volunteers [0.03%]
艾美恩韦尔与健康志愿者中的CYP3A介导的药动学相互作用研究：与咪达唑仑、环孢素和利托那韦的研究
Temitope Adeloye,Omair Sahgal,Adeep Puri et al.
Temitope Adeloye et al.
Amenamevir (formerly ASP2151) is a helicase-primase inhibitor being developed for the treatment of herpesvirus infection. Amenamevir is both a substrate and inducer of cytochrome P450 (CYP) 3A4. Three studies were done in healthy volunteers...
Oral Bioavailability and Pharmacokinetics of Nonanimal Chondroitin Sulfate and Its Constituents in Healthy Male Volunteers [0.03%]
透明质酸和非动物硫酸软骨素及其组分在健康男性受试者中的口服生物利用度及药代动力学研究
Nicola Volpi,Veronica Mantovani,Fabio Galeotti et al.
Nicola Volpi et al.
The pharmacokinetic profile of a new 800-mg tablet of nonanimal chondroitin sulfate (CS) (Mythocondro®, 800-mg tablets, Gnosis S.p.A., Italy) was investigated vs an animal CS in healthy volunteers for a total period of 48 hours. After a si...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2019 Apr;8(3):336-345. DOI:10.1002/cpdd.587 2019
Evaluation of Food and Spherical Carbon Adsorbent Effects on the Pharmacokinetics of Roxadustat in Healthy Nonelderly Adult Male Japanese Subjects [0.03%]
评价食物和球形碳吸附剂对健康年轻日本男性受试者罗沙司他药代动力学的影响
Tomohisa Shibata,Yuki Nomura,Akitsugu Takada et al.
Tomohisa Shibata et al.
Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor in late-stage clinical development for the treatment of anemia in chronic kidney disease. Spherical carbon adsorbent (SCA) is used in patients with chronic kidney disease...
Clinical Pharmacokinetics and Drug-Drug Interaction Potential for Coadministered SCY-078, an Oral Fungicidal Glucan Synthase Inhibitor, and Tacrolimus [0.03%]
SCY-078与他克莫司联合给药的临床药代动力学和药物相互作用潜力：一种口服抗真菌合成酶抑制剂
Stephen Wring,Gail Murphy,George Atiee et al.
Stephen Wring et al.
SCY-078 is an orally bioavailable triterpenoid glucan synthase inhibitor in clinical development as an intravenous and oral treatment of fungal infections caused by Candida and Aspergillus species. This was a sequential, single-center, open...
Comparative Bioavailability of Sildenafil 50-mg Film-Coated Tablets and 50-mg Orally Disintegrating Films in Healthy Mexican Subjects: Results From a Randomized, Open-Label, Crossover Study [0.03%]
一项在健康墨西哥人群中开展的随机开放标记交叉研究结果：比较西地那非50毫克薄膜包衣片和50毫克口腔速溶膜的生物利用度
Luis García Aguirre,Isabel Ruiz Olmedo,Araceli Medina Nolasco et al.
Luis García Aguirre et al.
An orally disintegrating film formulation of sildenafil 50 mg (CL Pharm Co, Ltd) was used in this study and compared to the market-available product film coated tablets (Viagra® , Pfizer, Mexico). The objective was to compare the pharmacok...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2019 Apr;8(3):404-410. DOI:10.1002/cpdd.599 2019
Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Bapineuzumab: A Single-Ascending-Dose Study in Patients With Mild to Moderate Alzheimer Disease [0.03%]
轻至中度阿尔茨海默病患者单次递增剂量皮下注射巴利珠单抗的药代动力学、药效学和安全性研究
Ming Lu,H Robert Brashear
Ming Lu
This study was designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending subcutaneous doses of bapineuzumab in patients with mild to moderate Alzheimer disease. Forty patients were randomized ...
Effects of Intrinsic Factors on the Clinical Pharmacokinetics of Vortioxetine [0.03%]
伏硫西临床药代动力学的内在影响因素分析
Grace Chen,George G Nomikos,John Affinito et al.
Grace Chen et al.
Vortioxetine is an antidepressant agent with multimodal activity that is approved for the treatment of major depressive disorder at doses of 5 to 20 mg once daily. Vortioxetine is a medium-clearance drug that undergoes extensive metabolism ...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2018 Nov;7(8):880-888. DOI:10.1002/cpdd.577 2018
Pharmacokinetics, Safety, and Tolerability of Rolapitant Administered Intravenously Following Single Ascending and Multiple Ascending Doses in Healthy Subjects [0.03%]
单次和多次递增剂量静脉注射罗拉匹坦在健康志愿者体内的药代动力学、安全性和耐受性
Xiaodong Wang,Zhi-Yi Zhang,Jing Wang et al.
Xiaodong Wang et al.
Rolapitant is a selective and long-acting neurokinin-1 receptor antagonist approved in an oral formulation in combination with dexamethasone and a 5-hydroxytryptamine type 3 receptor antagonist for the prevention of delayed chemotherapy-ind...
Pharmacokinetics of Co-Suspension Delivery Technology Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate (BGF MDI) and Budesonide/Formoterol Fumarate Dihydrate (BFF MDI) Fixed-Dose Combinations Compared With an Active Control: A Phase 1, Randomized, Single-Dose, Crossover Study in Healthy Adults [0.03%]
布地奈德/格隆溴铵/富马酸福莫特罗协同悬浮递送技术(BGF MDI)和布地奈德/富马酸福莫特罗(BFF MDI)固定剂量复方与阳性对照药的药代动力学比较：一项健康受试者中的序贯交叉I期试验
Andrea Maes,Paolo DePetrillo,Shahid Siddiqui et al.
Andrea Maes et al.
This randomized, phase 1, single-dose, crossover study (NCT02189304) compared the 12-hour pharmacokinetic (PK) and safety profiles of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler (BGF MDI) 320/14.4/10 μg and...