Single-Dose Bioequivalence Study of Elagolix Tablets 200 mg (Test Product) and Elagolix Tablets 200 mg (Reference Product) in Healthy Non-Pregnant, Non-Lactating Premenopausal Female Subjects Under Fasting Conditions [0.03%]
一项单次给药生物等效性研究:在空腹条件下,健康非孕、非哺乳绝经前女性受试者中200毫克Elagolix片剂(试验制剂)和200毫克Elagolix片剂(参比制剂)的生物等效性研究
Sudershan Kumar,Arshad Khuroo,Reshma Quadros et al.
Sudershan Kumar et al.
Elagolix is a short-acting oral gonadotropin-releasing hormone antagonist utilized for treating endometriosis-associated pain by rapidly suppressing gonadotropins and estradiol. Although well characterized in Western populations, clinical d...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Apr;15(4):e70053. DOI:10.1002/cpdd.70053 2026
Thorough QT Study on the Effect of Therapeutic and Supratherapeutic Dosing of Givinostat in Healthy Volunteers [0.03%]
格拉诺司特健康志愿者受试者群体的彻底QT研究(治疗剂量和超大治疗剂量)
Eugenio Mercuri,Barry Byrne,Tracey Willis et al.
Eugenio Mercuri et al.
Givinostat is a class I/II histone deacetylase inhibitor indicated for Duchenne muscular dystrophy (DMD). The study evaluated the effect of therapeutic and supratherapeutic givinostat doses on the QT/QTc interval. Healthy volunteers receive...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Mar;15(3):e70047. DOI:10.1002/cpdd.70047 2026
Effect of High-Fat Diet on Pharmacokinetics and Incidence of Adverse Reactions of Tacrolimus in Healthy Chinese Participants [0.03%]
高脂饮食对中国健康志愿者他克莫司药代动力学及不良反应影响研究
Xiufang Zhu,Lingxue Shi,Lan Yang et al.
Xiufang Zhu et al.
The effects of food on the pharmacokinetics (PKs) and safety of 1 mg Tacrolimus sustained-release Tacrolimus capsules in healthy Chinese subjects were investigated from one bioequivalence trial. The bioequivalence trial was designed as sing...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Mar;15(3):e70049. DOI:10.1002/cpdd.70049 2026
Pharmacokinetics and Bioequivalence of 2 Deutetrabenazine Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions [0.03%]
在华氏和餐后条件下氘代托苯扎明片在中国健康志愿者中的药代动力学及生物等效性研究
Dayong Xu,Pengkai Wang,Yuan Li et al.
Dayong Xu et al.
Deutetrabenazine, a deuterated vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved for the treatment of Huntington's disease (HD)-related chorea and tardive dyskinesia (TD). However, pharmacokinetics (PK) and bioequivalence (BE...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Mar;15(3):e70054. DOI:10.1002/cpdd.70054 2026
Pharmacokinetic Evaluation of a Fixed-Dose Combination of Pelubiprofen and Tramadol: A Randomized Crossover Relative Bioavailability Trial and a Fixed-Sequence Food-Effect Study in Healthy Volunteers [0.03%]
富马酸培洛proximization片与盐酸曲马多缓释片复方制剂的人体生物等效性和餐食影响评价临床试验研究
Bui Thi Tham,Tran Thi Ngan,Tran Van Anh et al.
Bui Thi Tham et al.
DW-1021 is a novel fixed-dose combination salt formulation containing pelubiprofen 45 mg and tramadol hydrochloride 45.9 mg (equivalent to 40.3 mg tramadol free base). Two open-label, phase I clinical studies were conducted in healthy Vietn...
Pharmacokinetic Comparison Between a Fixed-Dose Combination of Atorvastatin/Fenofibrate 20/145 mg and the Corresponding Individual Components [0.03%]
固定剂量阿托伐他汀/非诺贝特片(20/145毫克)与相应单药成分的药代动力学对比研究
Seungri Lee,Juyoung Khwarg,Sungyeun Bae et al.
Seungri Lee et al.
Co-administration of atorvastatin and fenofibrate has demonstrated clinical benefits in patients with dyslipidemia. To improve convenience and adherence, a fixed-dose combination (FDC) of the two agents has gained interest. This study aimed...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Mar;15(3):e70043. DOI:10.1002/cpdd.70043 2026
Results of a Phase 1 Study Assessing the Effect of CIN-102, a Novel Formulation of the Dopamine Receptor Antagonist Domperidone Designed to Treat Gastroparesis, on Cardiac Repolarization in Healthy Volunteers [0.03%]
评估CIN-102(多潘立酮的新型配方,设计用于治疗胃轻瘫)在健康志愿者中对心脏复极化影响的I期研究结果
Mary Bond,Brian Murphy,Brendan Doran et al.
Mary Bond et al.
CIN-102 is a deuterated form of domperidone in development for the treatment of acute, recurrent gastroparesis. This thorough QT study assessed the effects of CIN-102 on cardiac repolarization in 62 healthy volunteers. In this 4-period rand...
A Randomized, Double-Blind, Two-Treatment, Two-Period, Crossover Study Investigating the Systemic Bioavailability of a Novel Cocrystal Ubiquinol Formulation Compared with a Ubiquinone Formulation in Healthy Adults [0.03%]
一项随机、双盲、两制剂、两周期、交叉研究,调查新型辅晶型泛醌醇配方与泛异戊二烯二酮配方在健康成人中的全身生物利用度问题
Xuefeng Mei,Bingqing Zhu,Kshitij Soni et al.
Xuefeng Mei et al.
Coenzyme Q10 (CoQ10) is a naturally occurring biochemical cofactor found in all human cell membranes in two interconvertible forms: oxidized ubiquinone and reduced ubiquinol. Clinical studies indicate that different CoQ10 formulations have ...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Mar;15(3):e70042. DOI:10.1002/cpdd.70042 2026
Absolute Bioavailability and Absorption, Distribution, Metabolism, and Excretion of [14C]Xevinapant, a Potent, Oral, Small-Molecule IAP Inhibitor [0.03%]
Xevinapant(EVP-6595,LY3202772)的绝对生物利用度及其吸收、分布、代谢和排泄研究
Annick Menetrey,Valérie Nicolas-Metral,Marie-Claude Roubaudi-Fraschini et al.
Annick Menetrey et al.
This Phase 1, open-label, 2-part, single-dose study aimed to investigate the pharmacokinetics, metabolism, and excretion of xevinapant, a small molecule inhibitor of apoptosis proteins (IAPs), in healthy male subjects. Part 1 focused on det...
Pharmacokinetic and Bioequivalence Evaluation of Two Lercanidipine Hydrochloride Tablets in Healthy Chinese Volunteers [0.03%]
评价两种乐卡尼地平氢氯片在中国健康志愿者中的药代动力学和生物等效性
Biao Sun,Li Zhao,Fangliang Gan et al.
Biao Sun et al.
Lercanidipine hydrochloride is a third-generation dihydropyridine calcium channel blocker used to treat mild-to-moderate hypertension. The aim of this study is to compare the pharmacokinetic characteristics of lercanidipine hydrochloride ta...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Mar;15(3):e70045. DOI:10.1002/cpdd.70045 2026