Pharmacokinetics of Diazepam and Its Metabolites in Urine of Chinese Participants [0.03%]
中国人尿液中地西泮及其代谢产物的药代动力学研究
Le-le Wang,Xin-Xin Ren,Yi He et al.
Le-le Wang et al.
Background: Urine is conventionally used as a specimen to document diazepam-related crimes; however, few reports have described the pharmacokinetics of diazepam and its metabolites in urine. ...
Effect of Severe Renal Impairment on the Safety, Tolerability, and Pharmacokinetics of AMG 986 [0.03%]
严重肾功能不全对AMG 986的安全性、耐受性和药代动力学的影响
Ashit Trivedi,Omar Mather,Silvia Vega et al.
Ashit Trivedi et al.
Introduction: AMG 986 is a first-in-class, novel apelin receptor small molecule agonist initially developed for the treatment of heart failure (HF). The safety and pharmacokinetics (PK) of AMG 986 in participants with ren...
Bioequivalence and Safety Assessment of Two Formulations of Metformin Hydrochloride Sustained-Release Tablets (Yuantang® SR and Glucophage® XR) Under Fed Conditions in Healthy Chinese Adult Subjects: An Open-Label, Two-Way Crossover, Sequence Randomized Phase I Clinical Trial [0.03%]
盐酸二甲双胍缓释片(源堂®SR和格华止®XR)与参比制剂餐时生物等效性及安全性评价：一项在中国健康受试者中进行的开放标签、双周期、双交叉I期临床试验
Ming-Li Sun,Hui-Juan Liu,Xiang-Dong Luo et al.
Ming-Li Sun et al.
Objective: The purpose of this single-center, randomized, open, two-period, two-sequence crossover, single-dose administration, bioequivalence research was to evaluate the bioequivalence and safety of the generic formulat...
Clinical Trial
Drugs in R&D. 2022 Mar;22(1):51-60. DOI:10.1007/s40268-021-00377-w 2022
A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of Subcutaneous Eflapegrastim in Healthy Japanese and Caucasian Subjects [0.03%]
评估Eflapegrastem在健康日本人群和高加索人群中单次递增剂量的I 期、随机、双盲、针对安慰剂和阳性对照的安全性、耐受性、药代动力学和药效学特征的研究
Yoomin Jeon,Nora Lee,Seungjae Baek et al.
Yoomin Jeon et al.
Background: Eflapegrastim (Rolontis®) is a novel long-acting pegylated recombinant human granulocyte colony-stimulating factor (G-CSF). Eflapegrastim has been developed to reduce the duration and incidence of chemotherap...
Clinical Trial
Drugs in R&D. 2022 Mar;22(1):71-87. DOI:10.1007/s40268-021-00379-8 2022
Matthew William McCarthy
Matthew William McCarthy
On 2 June, 2021, the US Food and Drug Administration approved ibrexafungerp (formerly MK-3118 and SCY-078) for the treatment of vulvovaginal candidiasis, also known as vaginal yeast infection. Ibrexafungerp is the first drug approved in a n...
The Pitfalls of Abnormal Laboratory Value Interpretation in Vaccine Clinical Trials: The Example of Asymptomatic Transient Neutropenia [0.03%]
疫苗临床试验中异常实验室检查值解读的误区——无症状短暂性中性粒细胞减少病例分析
Venanzio Vella,Johannes E Schmidt,Giulia Luna Cilio et al.
Venanzio Vella et al.
Hematological and clinical chemistry measurements are an integral part of vaccine safety monitoring. While adopting a conservative approach is important to exclude potential risks for patients, the rationale and methodology underlying the a...
Pharmacokinetics and Bioequivalence of Sitagliptin Phosphate/Metformin Hydrochloride Tablets in Healthy Chinese Subjects: A Randomized, Open-Label, Crossover Study [0.03%]
磷酸西他列汀/盐酸二甲双胍复方片在中国健康受试者中的药代动力学及生物等效性：随机开放交叉研究
Ping Shi,Xin Liu,Ting Li et al.
Ping Shi et al.
Objective: Our objective was to evaluate the pharmacokinetics and bioequivalence of test and reference (JANUMET®) formulations of sitagliptin phosphate/metformin hydrochloride tablets at a single dose of 50 mg/850 mg. ...
Randomized Controlled Trial
Drugs in R&D. 2022 Mar;22(1):15-23. DOI:10.1007/s40268-021-00371-2 2022
Coenzyme Q10 in the Treatment of Heart Failure with Preserved Ejection Fraction: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial [0.03%]
辅酶Q10在射血分数保留的心力衰竭治疗中的应用：一项前瞻性、随机、双盲、安慰剂对照试验
Tal Y Samuel,Tal Hasin,Israel Gotsman et al.
Tal Y Samuel et al.
Background: Heart failure with preserved ejection fraction (HFpEF) is common in elderly people and is increasing in prevalence. No specific treatment for this condition exists. Coenzyme Q10 (CoQ10) is an essential cofacto...
Randomized Controlled Trial
Drugs in R&D. 2022 Mar;22(1):25-33. DOI:10.1007/s40268-021-00372-1 2022
The Anti-inflammatory Effect of Dexmedetomidine Administration on Patients Undergoing Intestinal Surgery: A Randomized Study [0.03%]
右美托咪定对接受肠道手术的患者的抗炎效应：随机研究
Rushuang Chen,Zhenming Kang,Yaduan Wang et al.
Rushuang Chen et al.
Background and objective: Dexmedetomidine is a highly selective α2-adrenergic receptor agonist with sedative, analgesic, anti-sympathetic and stress-reducing effects. It has been widely used as an adjunct for general ane...
Randomized Controlled Trial
Drugs in R&D. 2021 Dec;21(4):445-453. DOI:10.1007/s40268-021-00368-x 2021
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection [0.03%]
针对HBV感染的RNAi治疗药物VIR-2218的单剂量临床与临床前药代动力学研究
Sneha V Gupta,Marie C Fanget,Christopher MacLauchlin et al.
Sneha V Gupta et al.
Background and objective: VIR-2218 is an investigational N-acetylgalactosamine-conjugated RNA interference therapeutic in development for chronic hepatitis B virus (HBV) infection. VIR-2218 was designed to silence HBV tra...
Randomized Controlled Trial
Drugs in R&D. 2021 Dec;21(4):455-465. DOI:10.1007/s40268-021-00369-w 2021