Impact of Sampling Window Variability on Pharmacokinetic Parameters Estimated by Non-Compartmental Analysis: Case Studies of Various Types of Drugs [0.03%]
取样间隔变化对非 compartment 分析估算药动学参数的影响：不同类型药物实例分析
Kyosuke Takahashi,Kazuhiko Asari,Kazuhiko Hanada
Kyosuke Takahashi
Non-compartmental analysis (NCA) is commonly used to estimate pharmacokinetic (PK) parameters in individual participants during Phase 1 studies. PK sampling schedules are important for accurately characterizing a drug's PK profile. However,...
Pharmacokinetics and Safety of Single-Dose Apraglutide in Individuals with Normal and Impaired Hepatic Function: A Phase 1, Open-Label Trial [0.03%]
单剂量Apraglutide在肝功能正常和轻至中度受损受试者中的药代动力学和安全性：一项I期、开放标记试验
Gerard Greig,Justin Hay,Patricia Valencia et al.
Gerard Greig et al.
Intestinal failure-associated liver disease occurs in 20% to 30% of patients with short bowel syndrome and intestinal failure (SBS-IF). Apraglutide is a glucagon-like peptide-2 (GLP-2) analog in clinical development for the treatment of pat...
A Phase 1 Bioequivalence Study to Assess the Pharmacokinetics, Safety and Tolerability of Guselkumab After a Single-Dose Administration via Two Subcutaneous Injection Devices in Healthy Volunteers [0.03%]
一项桥接生物等效性研究，评估两种皮肤给药装置单次注射古塞库玛巴特在中国健康受试者中的药代动力学、安全性和耐受性
Angela Jeong,Kathleen Weisel,Dessislava Dimitrova et al.
Angela Jeong et al.
Guselkumab is approved for the treatment of psoriasis, psoriatic arthritis, as well as ulcerative colitis and Crohn's disease. Two delivery devices for subcutaneous (SC) injection previously had been approved for the administration of 100 m...
Effects of Gastric Acid Suppression, Cytochrome P4503A Inhibition and Induction, and Food on the Pharmacokinetics of Tinlarebant in Healthy Adults [0.03%]
胃酸抑制、细胞色素P450 3A抑制和诱导以及饮食对Tinlarabant在健康成人中药动学的影响
Thomas M Polasek,Kushal J Paneliya,Tom Lin et al.
Thomas M Polasek et al.
Tinlarebant is an oral retinol binding protein 4 antagonist in clinical development for geographic atrophy, an advanced stage of dry age-related macular degeneration, and Stargardt disease, an inherited juvenile-onset macular degeneration. ...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jan;15(1):e70009. DOI:10.1002/cpdd.70009 2026
Safety, Tolerability, and Pharmacokinetics of Mufemilast, a PDE4 Inhibitor, in Healthy Participants: A First-in-Human Phase 1 Study [0.03%]
健康参与者中用于评估PDE4抑制剂Mufemilast安全性和耐受性的药代动力学：一项首次人体I期研究
Xiuqi Li,Xiaofei Wu,Aihong Huo et al.
Xiuqi Li et al.
Phosphodiesterase 4 (PDE4) is a branch of the phosphodiesterase isoenzyme family and plays a crucial role in maintaining intracellular cAMP homeostasis. Mufemilast, a novel PDE4 inhibitor, has demonstrated anti-inflammatory effects in precl...
The Triple-Agonist Revolution: Retatrutide and the Paradigm Shift in Multi-Hormonal Pharmacotherapy for Obesity and Cardiometabolic Comorbidities [0.03%]
三 receptor 激动剂革命：Retatrutide 和肥胖及心血管代谢合并症多激素药物治疗范式的转变
Nila Ganamurali,Sarvesh Sabarathinam
Nila Ganamurali
Obesity has emerged as a global health crisis requiring innovative therapeutic strategies beyond conventional approaches. While glucagon-like peptide-1 (GLP-1) and dual GIP/GLP-1 receptor agonists have redefined pharmacological management, ...
Michael J Fossler,Brian Smith
Michael J Fossler
Effects of High- and Low-Fat Meals on the Bioavailability and Pharmacokinetics of Votoplam, a HTT Gene Splicing Modifier [0.03%]
高脂肪和低脂肪饮食对HTT基因剪接调节剂Votinib生物利用度和药代动力学的影响
Lucy Lee,Amy-Lee Richards,Nageswara Reddy et al.
Lucy Lee et al.
Votoplam is a novel, orally bioavailable, small molecule HTT gene splicing modifier that is being developed for the treatment of Huntington's disease. This was a single dose, open-label, two-period, crossover food effect study that evaluate...
Pharmacokinetics and Bioequivalence of Ilaprazole Enteric-Coated Tablets in Healthy Chinese Volunteers: A Two-Sequence, Four-Period, Fully Replicated Crossover Study [0.03%]
艾拉普唑肠溶片在健康受试者中的药代动力学及生物等效性研究：两序列四周期重复交叉试验
Lijie Du,Yi Zhang,Fangliang Gan et al.
Lijie Du et al.
Ilaprazole enteric-coated tablets are a novel proton pump inhibitor primarily used for the treatment of gastroesophageal reflux disease, with metabolism not affected by CYP2C19 genetic polymorphism. This study evaluated the pharmacokinetics...
A Phase 1, Randomized, Placebo-Controlled, Multiple-Dose, Double-Blind Study to Evaluate and Compare the Pharmacokinetics and Safety of Rimegepant in Healthy Adult Japanese and Caucasian Individuals [0.03%]
一项针对成年日本受试者和白人受试者的瑞美吉泮药代动力学和安全性评价的I期、随机双盲、安慰剂对照及多剂量递增试验
Rajinder Bhardwaj,Chay Ngee Lim,Yinhua Li et al.
Rajinder Bhardwaj et al.
This Phase 1, randomized, placebo-controlled, double-blind study assessed the pharmacokinetic profile of rimegepant (25, 75, or 150 mg once daily for 14 days) in healthy Japanese and Caucasian adults. Exposures were modestly increased in Ja...