Pharmacokinetics, Safety, and Tolerability of the Dual Inhibitor of Tumor Necrosis Factor-α and Interleukin 17A, ABBV-257, in Healthy Volunteers and Patients With Rheumatoid Arthritis [0.03%]
ABBV-257(一种抗肿瘤坏死因子α和抗白细胞介素17A的双效抑制剂)在健康志愿者和类风湿关节炎患者中的药代动力学、安全性和耐受性
Ahmed A Othman,Amit Khatri,Ralf Loebbert et al.
Ahmed A Othman et al.
The dual-variable domain immunoglobulin ABBV-257 binds tumor necrosis factor-α and interleukin 17A. Following single ascending doses ( 0.3, 1.0, and 3.0 mg/kg intravenously; 0.3 and 3.0 mg/kg subcutaneously) in a randomized, double-blind, ...
Pharmacokinetics and Comparative Bioavailability of a Levothyroxine Sodium Oral Solution and Soft Capsule [0.03%]
硫酸左甲状腺素口服溶液和软胶囊的药代动力学及生物等效性研究
Mario Tanguay,Johanne Girard,Claudia Scarsi et al.
Mario Tanguay et al.
A new formulation of levothyroxine sodium has been developed in the form of an oral solution contained in unit-dose ampules. A study has been conducted to compare the bioavailability of levothyroxine sodium oral solution and levothyroxine s...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2019 May;8(4):521-528. DOI:10.1002/cpdd.608 2019
Assessment of the Effects of Age and Renal Function on Pharmacokinetics of Bazedoxifene in Postmenopausal Women [0.03%]
评估年龄和肾功能对绝经后女性巴唑昔芬药代动力学影响的研究
William McKeand,James Ermer,Joan Korth-Bradley
William McKeand
Bazedoxifene (BZA), a chemically distinct selective estrogen receptor modulator, has demonstrated efficacy and long-term safety in phase 3 placebo-controlled studies for prevention and treatment of osteoporosis. Here, we assessed the potent...
Phase 1 Single- and Multiple-Ascending-Dose Randomized Studies of the Safety, Pharmacokinetics, and Pharmacodynamics of AG-348, a First-in-Class Allosteric Activator of Pyruvate Kinase R, in Healthy Volunteers [0.03%]
AG-348(一种第一类丙酮酸激酶R变构激活剂)在健康志愿者中的I期单剂量和多剂量递增研究:安全性、药代动力学和药效学特征
Hua Yang,Elizabeth Merica,Yue Chen et al.
Hua Yang et al.
Pyruvate kinase deficiency is a chronic hemolytic anemia caused by mutations in PK-R, a key glycolytic enzyme in erythrocytes. These 2 phase 1 randomized, placebo-controlled, double-blind healthy-volunteer studies assessed the safety, toler...
Open-Label, Crossover Study to Determine the Pharmacokinetics of Fluticasone Furoate and Batefenterol When Administered Alone, in Combination, or Concurrently [0.03%]
序贯和随机对照交叉给药的氟替卡松福莫特克吸入粉雾剂与乙酰异丙托溴铵/福莫特罗的研究:I期健康受试者中的药代动力学、安全性和耐受性
Claire Ambery,Graeme Young,Teresa Fuller et al.
Claire Ambery et al.
The study aim was to investigate the pharmacokinetics of single high doses and repeated therapeutic doses of fluticasone furoate (FF) and batefenterol (BAT; a bifunctional muscarinic antagonist and β2 -agonist) administered in combination ...
A Randomized, Double-Blind, Single-Dose, Crossover Study to Demonstrate the Bioequivalence of 2 Formulations of Albiglutide in Healthy Adult Participants [0.03%]
阿柏西普两种剂型在中国健康受试者中单次给药的随机、双盲、序贯生物等效性研究
Bonnie C Shaddinger,Georgios Vlasakakis,Joseph Soffer et al.
Bonnie C Shaddinger et al.
Albiglutide, developed for treatment of type 2 diabetes mellitus, is provided in a dual-chamber cartridge (DCC) single-dose pen-injector containing lyophilized drug that must be reconstituted with diluent prior to use. A liquid formulation ...
Bioequivalence of Olanzapine Given in Combination With Samidorphan as a Bilayer Tablet (ALKS 3831) Compared With Olanzapine-Alone Tablets: Results From a Randomized, Crossover Relative Bioavailability Study [0.03%]
一项随机交叉相对生物利用度研究:与单一奥氮平片剂相比,复层片剂(ALKS 3831)联合给药的奥氮平-萨米多酚烷与单用奥氮平片剂的生物等效性研究结果
Lei Sun,David McDonnell,Jianjun Liu et al.
Lei Sun et al.
The objective of this study was to evaluate the relative bioavailability of olanzapine in 3 olanzapine-containing tablet formulations. ALKS 3831 is a fixed-dose combination of olanzapine (OLZ, an atypical antipsychotic) and samidorphan (SAM...
Relative Bioavailability and Food Effect Evaluation for 2 Tablet Formulations of Asciminib in a 2-Arm, Crossover, Randomized, Open-Label Study in Healthy Volunteers [0.03%]
评价阿西米尼两种片剂制剂相对生物利用度及餐食影响的两周期、双臂、随机、开放标签的人体 bioavailability 研究
Hans D Menssen,Michelle Quinlan,Charisse Kemp et al.
Hans D Menssen et al.
Asciminib (ABL001) is an orally administered allosteric inhibitor of the BCR-ABL tyrosine kinase. The current study evaluated the relative bioavailability of its 2 tablet variants, AAA and NXA, compared with the capsule CSF and assessed the...
Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of Alicapistat, a Selective Inhibitor of Human Calpains 1 and 2 for the Treatment of Alzheimer Disease: An Overview of Phase 1 Studies [0.03%]
Alicapistat治疗阿尔茨海默病的人类钙蛋白酶1和2的选择性抑制剂的药代动力学,安全性,耐受性和药理动态:I期研究综述
Hoi-Kei Lon,Nuno Mendonca,Sandra Goss et al.
Hoi-Kei Lon et al.
Alicapistat is an orally active selective inhibitor of calpain 1 and 2 whose overactivation has been linked to Alzheimer disease (AD). Three studies were conducted in healthy subjects (18-55 years), 1 in healthy elderly subjects (≥65 years...