Effects of Food on the Pharmacokinetics and Safety of a Novel c-Met Inhibitor SPH3348: A Single-Center, Randomized, Open-Label, Single-Dose, 2-Period, 2-Sequence Crossover Study [0.03%]
食物对新型c-met抑制剂SPH3348药代动力学和安全性影响的单中心、随机、开放标签、单剂量、两周期交叉试验研究报告
Zhuo Chen,Qin Yu,Shiyin Feng et al.
Zhuo Chen et al.
This randomized, open-label, 2-period crossover study evaluated food effects on SPH3348 pharmacokinetics (PK) and safety in 16 healthy participants receiving a single 480-mg dose under fasting and high-fat fed conditions. PK profiling invol...
Exposure-Response Analysis for Aripiprazole Once-Monthly in Patients Diagnosed With Bipolar I Disorder [0.03%]
阿立哌唑一个月一次注射治疗I型双相情感障碍患者的暴露反应分析
Xiaofeng Wang,Luann Phillips,Matthew Harlin et al.
Xiaofeng Wang et al.
Aripiprazole once-monthly (AOM) is approved for the maintenance monotherapy treatment of bipolar I disorder (BP-I) in adults. A previously developed population pharmacokinetic model was validated by applying it to data from patients diagnos...
Pharmacokinetics and Pharmacodynamics of Faldaprevir Following Multiple Oral Rising Doses in Healthy Volunteers and Subjects with Gilbert's Syndrome [0.03%]
恩曲他滨富马酸替诺福韦二吡曱酯与利托那韦合用对健康志愿者体内法拉 Previr 药代动力学和药效学的影响
Mabrouk Elgadi,Chan-Loi Yong,Jan Wruck et al.
Mabrouk Elgadi et al.
Faldaprevir (FDV) is an investigational NS3/NS4A protease inhibitor for chronic hepatitis C. This study evaluated the safety, tolerability, and pharmacokinetics (PK) of FDV after multiple rising doses in healthy male volunteers and subjects...
Safety, Tolerability, and Pharmacokinetics of the Long-Acting SARS-CoV-2-Neutralizing Monoclonal Antibody Combination AZD7442 (Tixagevimab/Cilgavimab) in Healthy Chinese Adults [0.03%]
AZD7442(Tixagevimab/ cilgavimab)在健康中国受试者中的安全性，耐受性和药代动力学研究：一项随机，双盲，安慰剂对照的I期临床试验
Nanyang Li,Jing Zhang,Wenhong Zhang et al.
Nanyang Li et al.
AZD7442, a combination of extended half-life monoclonal antibodies tixagevimab and cilgavimab, was shown to neutralize previously circulating SARS-CoV-2 variants. This study evaluated safety, tolerability, pharmacokinetics, and pharmacodyna...
Pharmacokinetics and Bioequivalence of a Novel Extended-Release Formulation of Methylphenidate Hydrochloride for Attention-Deficit/Hyperactivity Disorder [0.03%]
一种新型哌甲酯缓释制剂的药代动力学及生物等效性研究
Ann C Childress,Ahmad Al-Sabbagh,Jeffrey H Newcorn
Ann C Childress
Extended-release (ER) formulations of the stimulant methylphenidate are commonly used to treat attention-deficit/hyperactivity disorder in both children and adults. Previous studies have shown that the clinical effectiveness of long-acting ...
First-in-Human Study of Merotocin, a Short-Acting Peptidic Oxytocin Receptor Agonist for Lactation Support [0.03%]
用于支持泌乳的短效肽类缩宫素受体激动剂Merotocin的人体首次研究
Yu Bagger,Carina Holmqvist,Daniël M Jonker et al.
Yu Bagger et al.
Endogenous oxytocin plays an important role in lactation, but its effectiveness as an exogenous galactagogue has been modest due to dose-limiting side effects related to off-target effects at the vasopressin V2 receptor. Merotocin (FE 20276...
Evaluation of the Pharmacokinetics, Bioequivalence, and Safety of Two Preparations of 20-mg Trimetazidine in Healthy Chinese Subjects [0.03%]
评价两种他克莫司片剂在中国健康受试者中的药代动力学、生物等效性及安全性
Dongmei Tan,Fucai Zhang,Xihua Fu et al.
Dongmei Tan et al.
In this study, we assessed the pharmacokinetics, safety, and bioequivalence of trimetazidine tablets from 2 different manufacturers in healthy Chinese individuals under both fasting and fed conditions. Twenty-eight healthy Chinese volunteer...
Comparative Analysis of Therapeutic Methods for Sudden Sensorineural Hearing Loss [0.03%]
突发性特发性感音神经性聋治疗方法的Meta分析
Lingling Di,Hui Yong,Zhikai Wang et al.
Lingling Di et al.
This prospective study compared the therapeutic efficacy of Ginaton alone, Ginaton combined with glucocorticoids, or Ginaton with mouse nerve growth factor (mNGF) in patients with sudden sensorineural hearing loss (SSNHL). Between January 2...
Honoring the Extensive and Impactful Contributions of Prof David J Greenblatt, MD: Founding Editor of Clinical Pharmacology in Drug Development [0.03%]
致敬David J Greenblatt教授对药物开发临床药理学的杰出贡献
Vikram Arya,Michael Fossler,Oliver Grundmann
Vikram Arya
Editorial: Early Phase Innovation-Adapting to the New Age of Accelerated Drug Approvals [0.03%]
editorial:早期创新——适应加速批准新时代
Amalia M Issa
Amalia M Issa