The FDA Roadmap to Reducing Animal Testing in Preclinical Safety Studies: Where Will It Lead Us? [0.03%]
美国FDA临床前安全研究减少动物实验路线图：它会把我们带向何方？
Michael J Fossler,C Edwin Garner
Michael J Fossler
Pharmacokinetic Characterization and Bioequivalence of Sildenafil Citrate Orally Disintegrating Tablets in Healthy Volunteers [0.03%]
西地那非口崩片的药代动力学特征及与片剂的生物等效性研究
Yi Zhang,Lijie Du,Shirong Liu et al.
Yi Zhang et al.
This study characterized the pharmacokinetic (PK) profile and evaluated the bioequivalence of sildenafil citrate under fasting conditions in Chinese subjects. A single-center, randomized, open-label, single-dose, two-sequence, two-period cr...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Mar;15(3):e70041. DOI:10.1002/cpdd.70041 2026
Pharmacokinetic and Bioequivalence Evaluation of Two Repaglinide Tablets Under Fasting and Fed Conditions in Healthy Chinese Volunteers [0.03%]
评价两种瑞格列奈片空腹及餐后状态下的药代动力学及生物等效性试验（健康受试者）
Biao Sun,Li Zhao,Fangliang Gan et al.
Biao Sun et al.
Repaglinide, an insulin secretagogue that predominantly lowers postprandial glucose, is approved for patients with type 2 diabetes inadequately controlled by diet, weight loss, and exercise. This study used a single-center, randomized, open...
Single-Dose Pharmacokinetic Assessment of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets): Results From Randomized, Open-Label Studies in Healthy Volunteers [0.03%]
一项在健康志愿者中进行的TNX-102 SL（环苯扎林氢化可的松口腔速释片）单剂量药代动力学评估的随机开放标签研究结果
Bruce L Daugherty,Bernd Meibohm,Gregory M Sullivan et al.
Bruce L Daugherty et al.
Daily oral cyclobenzaprine hydrochloride (HCl) has provided transient benefits in fibromyalgia, a chronic pain condition. To improve this effect, we evaluated sublingual formulations designed to drive transmucosal absorption. Two open-label...
Pharmacokinetics and Safety of VV116 in Subjects With Mild or Moderate Hepatic Impairment Compared With Healthy Controls: A Phase I, Open-Label Study [0.03%]
与健康受试者相比，VV116在轻中度肝功能受损患者中的药代动力学和安全性：I期开放标记研究
Xi Tan,Tong Lu,Shijuan Kuang et al.
Xi Tan et al.
VV116 (Mindvy, JT001) is a deuterated oral derivative of remdesivir hydrobromide developed for the treatment of COVID-19. Because hepatic dysfunction may influence drug exposure, this Phase 1, open-label, parallel-group study characterized ...
Bioequivalence Between a Gantenerumab Disposable Syringe and an Autoinjector: A Randomized Controlled Trial in Healthy Volunteers [0.03%]
一项在健康志愿者中的随机对照试验：关于gantenerumab预充式注射器与自动注射器生物等效性的试验
Dietmar Schwab,Carsten Hofmann,Nicole Justies et al.
Dietmar Schwab et al.
Gantenerumab, a monoclonal antibody targeting amyloid beta plaques in the brain, reduces plaque accumulation and was developed to slow Alzheimer's disease progression. Results from the pivotal GRADUATE I and II studies evaluating gantenerum...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Feb;15(2):e70038. DOI:10.1002/cpdd.70038 2026
Pharmacokinetics of Aztreonam-Avibactam After Single- and Multiple-Dose Administration: A Phase 1, Open-Label Study in Healthy Chinese Participants and Ethnic Comparison with Non-Chinese Participants [0.03%]
阿维巴坦-亚胺培南在中国受试者中的药代动力学：一项单次和多次给药剂量的I期开放性研究及与非中国人受试者比较
Jingjing Wang,Jinjie He,Jufang Wu et al.
Jingjing Wang et al.
Combined treatment with aztreonam (an established intravenous antibiotic) and avibactam (a β-lactamase inhibitor) has the potential to address the unmet need for safe and effective agents to combat infections caused by Gram-negative bacter...
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Phase 1 Study of Firsekibart in Chinese Healthy Participants [0.03%]
塞西白artin片在健康受试者中的随机、双盲、安慰剂对照、多剂量递增I期临床试验
Xiaolan Yong,Xiaolin Du,Xiao Li et al.
Xiaolan Yong et al.
Firsekibart is an anti-IL-1β monoclonal antibody for treating acute gout flares in adults. This randomized, double-blind, placebo-controlled study assessed the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of multiple asce...
Effect of Renal Impairment on the Pharmacokinetics and Safety of Doxecitine and Doxribtimine: A Single-Dose Phase 1 Study [0.03%]
肾功能损害对多西替丁和多索法林单剂量药代动力学和安全性的效果：Ⅰ期临床试验
Aravind Mittur,Susan A VanMeter
Aravind Mittur
This Phase 1 study investigated the pharmacokinetics and safety of a single dose of the FDA-approved doxecitine and doxribtimine (266.6 mg/kg; 133.3 mg/kg of deoxycytidine [dC] and deoxythymidine [dT]) in participants with severe (n = 8) or...
Phase 1 Study Evaluating the Effects of Single-Dose Frespaciguat, an Inhaled Soluble Guanylate Cyclase Stimulator, Co-administered with Multiple-Dose Sildenafil on Systemic Hemodynamics [0.03%]
单次吸入FRespaciuguat（一种可溶性鸟苷酸环化酶刺激剂）与多次西地那非对全身血动力学影响的Ⅰ期研究
Ednan K Bajwa,Dawn Cislak,John Palcza et al.
Ednan K Bajwa et al.
Co-administration of oral phosphodiesterase 5 inhibitors with oral soluble guanylate cyclase (sGC) stimulators is contraindicated due to the risk of systemic side effects. Frespaciguat, an inhaled sGC stimulator, has been studied in pulmona...