Pharmacokinetic Profile of a Generic Formulation of Sofosbuvir and Its Metabolite GS-331007 in Healthy Chinese Subjects [0.03%]
索磷布韦国产仿制药及其代谢产物GS-331007在中国健康志愿者中的药代动力学特征
Zhenwei Shen,Xiaoxue Zhu,Hong Zhang et al.
Zhenwei Shen et al.
Sofosbuvir is an NS5B nucleotide inhibitor for the treatment of hepatitis C viral infection. In this study the pharmacokinetics (PK) and safety of single and multiple doses of generic sofosbuvir were investigated in healthy Chinese subjects...
Pharmacokinetic Properties of Ibuprofen (IBU) From the Fixed-Dose Combination IBU/Caffeine (400/100 mg; FDC) in Comparison With 400 mg IBU as Acid or Lysinate Under Fasted and Fed Conditions-Data From 2 Single-Center, Single-Dose, Randomized Crossover Studies in Healthy Volunteers [0.03%]
一项在健康志愿者中进行的单剂量、随机交叉研究数据：与空腹或餐后给予400 mg 布洛芬（酸或左旋 Arginine 盐）相比，含布洛芬/咖啡因固定剂量复方制剂（400/100毫克；FDC）的药动学性质
Thomas Weiser,Cornelia Schepers,Tobias Mück et al.
Thomas Weiser et al.
Rapid onset of analgesic action is linked with rapid absorption of analgesics (high maximum concentration [Cmax ] and short time to maximum concentration [tmax ]). After overnight fasting, ibuprofen lysinate reaches higher peak plasma level...
Drug-Drug Interactions of Tacrolimus or Cyclosporine With Glecaprevir and Pibrentasvir in Healthy Subjects [0.03%]
他克莫司或环孢素与 glecaprevir 和 pibrentasvir 在健康志愿者中的药物相互作用研究
Matthew P Kosloski,Weihan Zhao,Hong Li et al.
Matthew P Kosloski et al.
A fixed-dose combination of glecaprevir and pibrentasvir is approved for treatment of chronic infection with hepatitis C virus (HCV) genotypes 1-6. Three phase 1 open-label studies were conducted in healthy volunteers to evaluate the potent...
A Randomized, Double-Blind, Placebo-Controlled, First-Time-in-Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of GSK3389404 in Healthy Subjects [0.03%]
GSK3389404在健康受试者中的I期随机双盲安慰剂对照首次人体试验，以评估单次和多次递增剂量给药后的安全性、耐受性和药代动力学特征
Kelong Han,Jennifer Cremer,Robert Elston et al.
Kelong Han et al.
GSK3389404 is a liver-targeted antisense oligonucleotide that inhibits synthesis of hepatitis B surface antigen and all other hepatitis B virus proteins. This first-in-human, randomized, double-blind, phase 1 study assessed the safety and p...
Pharmacokinetics of Tacrolimus Coadministered With Letermovir in Allogeneic Hematopoietic Stem Cell Transplantation Patients [0.03%]
接受环孢素治疗的地西他滨初治急性髓系白血病患者中的替莫唑胺剂量 escalation：一项 Ib 期研究
Yong-Mei Guo,Maiko Abumiya,Takaya Yamashita et al.
Yong-Mei Guo et al.
A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Cabotegravir in Patients With Hepatic Impairment and Healthy Matched Controls [0.03%]
一项在肝功能不全患者和健康匹配受试者中评估卡博特格拉维的药代动力学和安全性的I期研究
Jafar Sadik B Shaik,Susan L Ford,Yu Lou et al.
Jafar Sadik B Shaik et al.
Cabotegravir is an investigational integrase inhibitor in development for the treatment and pre-exposure prophylaxis of HIV-1 infection. Liver disease is a major cause of morbidity and mortality in HIV-infected individuals and can impact th...
A Phase I Study to Evaluate the Pharmacokinetics and Safety of Cabotegravir in Adults With Severe Renal Impairment and Healthy Matched Control Participants [0.03%]
一项I期研究：评估卡博特格拉韦在重度肾功能不全成人受试者和匹配健康对照受试者中的药代动力学和安全性
Ridhi Parasrampuria,Susan L Ford,Yu Lou et al.
Ridhi Parasrampuria et al.
This study investigates the impact of severe renal impairment on the pharmacokinetics of cabotegravir, an investigational HIV-1 integrase inhibitor. This was a phase I, open-label, parallel-group, multicenter study conducted in 8 participan...
Study on Drug-Drug Interactions Between Chiglitazar, a Novel PPAR Pan-Agonist, and Metformin Hydrochloride in Healthy Subjects [0.03%]
氯格列扎尔与盐酸二甲双胍在健康受试者中相互作用的研究
Ling Yi,Hua Zhang,Jin-Wen Zhang et al.
Ling Yi et al.
Chiglitazar (CHI) is a potent and selective peroxisome proliferator-activated receptor potentially for the treatment of patients with type 2 diabetes mellitus (T2DM). An open-label, randomized, 3-period crossover and self-controlled study w...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2019 Oct;8(7):934-941. DOI:10.1002/cpdd.668 2019
A Phase 1, Open-Label, Pharmacokinetic Trial to Investigate Possible Drug-Drug Interactions Between Clobazam, Stiripentol, or Valproate and Cannabidiol in Healthy Subjects [0.03%]
健康受试者中依非地平、氯巴扎或 valproate 对大麻二酚药代动力学的药物相互作用一期开放标签临床试验
Gilmour Morrison,Julie Crockett,Graham Blakey et al.
Gilmour Morrison et al.
GW Pharmaceuticals' formulation of highly purified cannabidiol oral solution is approved in the United States for seizures associated with Lennox-Gastaut and Dravet syndromes in patients aged ≥2 years, for which clobazam, stiripentol, and ...
A Phase 3, Randomized, Placebo-Controlled Evaluation of the Safety of Intravenous Meloxicam Following Major Surgery [0.03%]
万络术后静脉给药Ⅲ期临床研究
Sergio D Bergese,Timothy I Melson,Keith A Candiotti et al.
Sergio D Bergese et al.
An intravenous (IV) formulation of meloxicam is being studied for moderate to severe pain management. This phase 3, randomized, multicenter, double-blind, placebo-controlled trial evaluated the safety of once-daily meloxicam IV 30 mg in sub...