Tramadol Hydrochloride at Steady State Lacks Clinically Relevant QTc Interval Increases in Healthy Adults [0.03%]
在稳态下盐酸曲马多对健康成年人的QTc间期无临床意义的影响
Joseph Massarella,Jay Ariyawansa,Jaya Natarajan et al.
Joseph Massarella et al.
We evaluated the effects of therapeutic and supratherapeutic doses of tramadol hydrochloride on the corrected QT (QTc) interval in healthy adults (aged 18-55 years) in a randomized, phase I, double-blind, placebo- and positive-controlled, m...
Pharmacokinetics and Target Attainment of Ceftobiprole in Asian and Non-Asian Subjects [0.03%]
赛托溴铵在亚洲人和非亚洲人体内的药代动力学及目标达成研究
A E Muller,N Punt,M Engelhardt et al.
A E Muller et al.
Ceftobiprole is a broad-spectrum cephalosporin. The objective of this study was to test the hypothesis that the pharmacokinetics (PK) and exposure of ceftobiprole in Asian subjects are similar to those in non-Asian subjects. Three approache...
Open-Label, Dose-Escalation, Phase 1 Study of Safety and Single and Multiple-Dose Pharmacokinetics of Dichlorphenamide in Healthy Volunteers [0.03%]
健康志愿者接受二氯酚海因开放标记、剂量递增的I期研究的安全性以及单次和多次给药的药物代谢动力学研究
Fredric Cohen
Fredric Cohen
Single-and multiple-dose pharmacokinetics and safety were investigated in this phase 1 study of dichlorphenamide, a carbonic anhydrase inhibitor approved in the United States for treatment of primary periodic paralysis. Dichlorphenamide was...
Bioequivalence Evaluation of Two Oral Formulations of Acetaminophen in Healthy Subjects: Results From a Randomized, Single-Blind, Crossover Study [0.03%]
对乙酰氨基酚两种口服剂型的生物等效性评价：一项单盲随机对照交差试验结果
Luis García Aguirre,Carlos Bohorquez Nassar,Isabel Ruiz Olmedo et al.
Luis García Aguirre et al.
Despite widespread availability of acetaminophen in Mexico, data on its pharmacokinetic properties in Mexican populations are limited. This single-center, single-blind, randomized, 2-period, 2-treatment, crossover, single-dose-per-period, 2...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2019 Jan;8(1):9-15. DOI:10.1002/cpdd.469 2019
Comparative Randomized, Single-Dose, Two-Way Crossover Open-Label Study to Determine the Bioequivalence of Two Formulations of Dalfampridine Tablets [0.03%]
达法普林片两种制剂单剂量、双交叉开放 label 试验的 bioequivalence 研究比较
Abdel Qader Al Bawab,Bashar A Alkhalidi,Esra&#x;a Albarahmieh et al.
Abdel Qader Al Bawab et al.
Dalfampridine is a medication that is approved by the US Food and Drug Administration to improve walking impairments in patients with multiple sclerosis (MS). The branded dalfampridine is enormously expensive; hence, the availability of gen...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2019 Apr;8(3):355-360. DOI:10.1002/cpdd.574 2019
An Open-Label, Phase 1 Study to Assess the Effects of Hepatic Impairment on Pomalidomide Pharmacokinetics [0.03%]
一项开放标签1期研究：评估肝功能损害对泊马西尼药代动力学的影响
Yan Li,Xiaomin Wang,Liangang Liu et al.
Yan Li et al.
Pomalidomide is an immunomodulatory drug and the dosage of 4 mg per day taken orally on days 1-21 of repeated 28-day cycles has been approved in the European Union and United States to treat patients with relapsed/refractory multiple myelom...
Formulation and In Vitro, In Vivo Correlation Between Two Candesartan Cilexetil Tablets [0.03%]
坎地沙坦酯片的处方研究及体外、体内相关性研究
Abdel Naser Zaid,Asma Radwan,Nidal Jaradat et al.
Abdel Naser Zaid et al.
In this study, the in vitro and in vivo interchangeability between generic candesartan 16 mg and the branded formulation was assessed. The in vitro release of these products was conducted in 3 pH media (1.2, 5.0, and 6.8), and similarity fa...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2018 Aug;7(6):621-626. DOI:10.1002/cpdd.460 2018
Does Dapagliflozin Affect Energy Intake and Appetite? A Randomized, Controlled Exploratory Study in Healthy Subjects [0.03%]
达格列净影响能量摄入和食欲吗？一项在健康受试者中的随机、对照探索性研究
Elizabeth Bertran,Helen D Berlie,Aaron Nixon et al.
Elizabeth Bertran et al.
The primary aims of this study were to assess the effects of dapagliflozin versus placebo on energy intake and appetite ratings in healthy individuals. This was a randomized, single-blind, placebo-controlled, 2-period crossover study. In ea...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2019 Jan;8(1):119-125. DOI:10.1002/cpdd.461 2019
Pharmacokinetic and Pharmacodynamic Correlations From 2 Studies Evaluating Abuse Potential of Hydrocodone Extended-Release Tablets [0.03%]
关于氢可酮缓释片药物滥用潜力的两项研究中的药代动力学和药效学相关性分析
Kerri A Schoedel,Michael Gillespie,Naama Levy-Cooperman et al.
Kerri A Schoedel et al.
Pharmacokinetic (PK)/pharmacodynamic (PD) correlations were explored in 2 human abuse potential studies of orally and intranasally administered hydrocodone extended-release (ER) 45 mg in healthy, nondependent opioid users. In a crossover st...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2019 Jan;8(1):32-39. DOI:10.1002/cpdd.468 2019
Pharmacokinetic Interaction Between Fingolimod and Carbamazepine in Healthy Subjects [0.03%]
健康受试者中芬戈利莫德与卡马西平的药代动力学相互作用
Olivier J David,Rhett Behrje,Parasar Pal et al.
Olivier J David et al.
This open-label, single-sequence study in healthy subjects investigated the effects of steady-state carbamazepine on the pharmacokinetic (PK) profile of a single 2-mg dose of fingolimod. In period 1, a single oral dose of fingolimod 2 mg (d...