Bioequivalence of a Fixed-Dose Combination of Relugolix, Estradiol, and Norethindrone Acetate: An Open-Label, Randomized, Fully Replicate Crossover Study in Healthy Postmenopausal Women Under Fasting Conditions [0.03%]
一项在健康绝经后妇女中进行的空腹条件下鲁克索利姆固定剂量组合、雌二醇和炔诺酮乙酸酯生物等效性开放标签、随机、完全交叉研究
Ravi Kotadia,Sudershan Kumar,Arshad Khuroo et al.
Ravi Kotadia et al.
Uterine fibroids are the most common benign gynecological tumors, often causing heavy menstrual bleeding (HMB), anemia, and impaired quality of life. A fixed-dose combination (FDC) of relugolix (40 mg), estradiol (1 mg), and norethindrone a...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jun;15(6):e70076. DOI:10.1002/cpdd.70076 2026
A Phase 1 Study to Assess the Relative Bioavailability of Brigatinib Administered as an Oral Solution Versus an Immediate-Release Tablet in Healthy Adults [0.03%]
brigatinib口服溶液剂与立即释放片剂在健康成人受试者中的I期相对生物利用度桥接试验
Michael J Hanley,Ronald Gounden,Bradley Hupf et al.
Michael J Hanley et al.
Brigatinib is an ALK tyrosine kinase inhibitor approved for the treatment of adults with ALK+ non-small cell lung cancer. The commercial formulation of brigatinib is an immediate-release (IR) tablet; however, an oral solution was developed ...
Population Pharmacokinetic-Based Meropenem Dosing in Critically and Non-Critically Ill Patients with Mixed Gram-Negative Bacterial Infections [0.03%]
基于群体药代动力学的多重心内杂菌感染重症及非重症患者的美罗培南用药剂量研究
Shuo Shi,Jie Cui,Guangqing Liu et al.
Shuo Shi et al.
This study aimed to describe the population pharmacokinetic (PK) of meropenem in patients with mixed Gram-negative bacterial infections, and further to develop optimal dosing regimens for both non-critically ill and critically ill patients ...
Effect of High-Fat Meal on the Pharmacokinetics and Safety of Lansoprazole Enteric-Coated Capsules in Healthy Chinese Subjects [0.03%]
高脂饮食对兰索拉唑肠溶胶囊在中国健康受试者中药动学及安全性的影响
Yifei Wang,Xiaojing Huang,Dandan Han et al.
Yifei Wang et al.
The effects of food on the pharmacokinetics (PKs) and safety of 30-mg lansoprazole enteric-coated capsules in healthy Chinese subjects were investigated from a bioequivalence trial. A randomized, open-label, four-period crossover study was ...
Michael J Fossler,Katy P Moore
Michael J Fossler
Pacritinib Impact on QT Interval: Results of a Thorough QT Study and Post Hoc Analysis of Prospective Clinical Trial Data [0.03%]
Pacritinib对QT间期的影响： thorough QT研究及前瞻性临床试验数据的事后分析结果
Sarah A Buckley,Suliman Al-Fayoumi,James P Dean et al.
Sarah A Buckley et al.
Pacritinib, an inhibitor of JAK2/IRAK1/ACVR1 that is devoid of JAK1 activity, approved for treating myelofibrosis in patients with severe thrombocytopenia, carries a label warning for QT interval prolongation. To evaluate the cardiac safety...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jun;15(6):e70070. DOI:10.1002/cpdd.70070 2026
Pharmacokinetics and Tolerability of Entacapone, Levodopa, and Carbidopa Tablets in Healthy Chinese Subjects: A Randomized, Open-Label, Four-Period Crossover Study Under Fasting and Fed Conditions [0.03%]
关于恩他卡朋复方片、左旋多巴和卡比多巴片在中国健康志愿者中的药代动力学及耐受性：在空腹及餐后条件下的四周期交叉开放标示量研究
Jingyan Wang,Yuan Xu,Ye Tao et al.
Jingyan Wang et al.
This study aimed to assess the pharmacokinetics, bioequivalence, and safety of a generic entacapone/levodopa/carbidopa (100/25/200 mg) tablet formulation compared to its reference listed drug (RLD, Stalevo) in healthy Chinese adults. A rand...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jun;15(6):e70071. DOI:10.1002/cpdd.70071 2026
Comparative Pharmacokinetics of Two Extended-Release Tablet Formulations of Upadacitinib: Bioequivalence Assessment [0.03%]
乌帕替尼两种延长释放片剂型的比较药代动力学：生物等效性评估
Biao Sun,Li Zhao,Fangliang Gan et al.
Biao Sun et al.
The aim of this study is to evaluate the pharmacokinetic characteristics, bioequivalence, and safety of two brands of upadacitinib (UPA) extended-release tablets (15 mg) in healthy Chinese subjects under fasting and postprandial conditions....
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jun;15(6):e70073. DOI:10.1002/cpdd.70073 2026
Randomized Phase 1 Studies Evaluating the Safety, Tolerability, Pharmacokinetics, and Target Occupancy of Zampilimab in Healthy Participants [0.03%]
在健康受试者中评估扎匹利单抗的安全性、耐受性、药代动力学和靶点占用的I期随机试验
Jo Collier,Rowann Bowcutt,Geoffrey I Johnston et al.
Jo Collier et al.
Zampilimab (UCB7858) is a humanized monoclonal immunoglobulin G4P, transglutaminase 2 (TG2) inhibiting antibody. We investigated safety, tolerability, pharmacokinetics, and target occupancy of zampilimab (intravenous ≤2000 mg; subcutaneous...
A Phase 1, Open-Label, Single-Dose Study of the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib, an FGFR Inhibitor [0.03%]
一项I期、开放标签、单次递增剂量考察肝功能损害对成纤维细胞生长因子受体抑制剂厄达菲替尼药代动力学影响的研究
Wei Zhu,Peter Hellemans,Anna Mitselos et al.
Wei Zhu et al.
Erdafitinib, an oral pan-FGFR inhibitor is extensively metabolized in the liver. This open-label, single-dose, phase 1 study evaluated the pharmacokinetics (PK) of erdafitinib in participants with hepatic impairment versus healthy controls....