A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Intranasal Dose of Zavegepant in Healthy Chinese Adults [0.03%]
一项在健康中国成人中评估单次鼻内给药扎沃加畔的药代动力学、安全性和耐受性的1期开放标签研究
Qiong Wei,Jufang Wu,Yangyi Dai et al.
Qiong Wei et al.
Zavegepant is the only calcitonin gene-related peptide antagonist approved as a nasal spray in the United States for acute treatment of migraine in adults with or without aura. This Phase 1, open-label study evaluated the pharmacokinetics, ...
Concentration-QTc Modeling to Support Clinical Development of Fezolinetant [0.03%]
用于支持非那林坦临床开发的浓度-QTc模型研究
Jace C Nielsen,Masako Saito,Xuegong Wang et al.
Jace C Nielsen et al.
Fezolinetant is a non-hormonal, selective neurokinin-3 receptor antagonist that blocks neurokinin B activation of kisspeptin/neurokinin B/dynorphin neurons to thereby modulate neuronal activity in the thermoregulatory center. Fezolinetant h...
Plazomicin Pharmacokinetics in Indian Complicated Urinary Tract Infections Patients: A Subgroup Analysis From Phase 2 Study [0.03%]
帕拉美星治疗复杂性尿路感染中国患者的药代动力学亚组分析：II期临床试验结果
Vaishali Gupte,Sandesh Sawant,Senthilnathan Mohanasundaram et al.
Vaishali Gupte et al.
Multidrug-resistant Enterobacteriaceae are a primary cause of complicated urinary tract infections (cUTIs) worldwide. This study compared pharmacokinetic (PK) parameters of plazomicin among Indian versus non-India participants. This was a p...
A Phase 1, Randomized, Open-Label, Parallel Group Study to Evaluate the Relative Bioavailability and Safety of Subcutaneous Bepirovirsen when Delivered from a Vial or Prefilled Syringe Fitted with a Safety Syringe Device in Healthy Adult Participants [0.03%]
一项在健康成人受试者中评估Bepirovirsen注射液来自西林瓶或预装安全注射针筒中的相对生物利用度和安全性的I 期、随机、开放标签、平行组研究
Amir S Youssef,Poonam Shah,Maxwell Hu et al.
Amir S Youssef et al.
Bepirovirsen, an antisense oligonucleotide in development for the treatment of chronic hepatitis B virus (HBV) infection, is administered from glass vials as a subcutaneous (SC) injection by healthcare professionals (HCPs). A ready-to-use p...
Pharmacokinetics and Bioequivalence of two Empagliflozin Tablet Formulations: Results From a Randomized, Open-Label, Crossover Study in Fasting Healthy Volunteers [0.03%]
一项在禁食健康受试者中进行的随机、开放标签、交叉试验的结果：两种恩格列净片剂制剂的药代动力学和生物等效性
Kar Ming Yee,Elton Sagim,Chuei Wuei Leong et al.
Kar Ming Yee et al.
This study aimed to assess the bioequivalence of a newly developed generic formulation of empagliflozin in comparison with the reference product. A total of 32 healthy adult volunteers participated in an open-label, randomized, balanced, tw...
Bioequivalence and Safety of Two Oseltamivir Phosphate for Oral Suspension in Healthy Chinese Subjects Under Fasting and Fed Conditions: A Randomized, Open‑Label, Single‑Dose, Crossover Study [0.03%]
奥司他韦口服悬液剂型在中国健康人群中的生物等效及餐食效应评价：一项随机、开放标签、单次给药、两制剂交叉试验
Yu Peng,Ming Zhou,Hegui Yan et al.
Yu Peng et al.
This randomized, open-label, single-dose crossover study evaluated the bioequivalence of a Chinese-manufactured oseltamivir phosphate oral suspension (7.5 mg/12.5 mL) against Tamiflu under fasting and fed conditions. A total of 42 healthy C...
Pharmacokinetics, Bioequivalence, and Safety of Bromocriptine Mesylate Tablets in HealthyChinese Subjects [0.03%]
甲磺酸溴隐亭片在中国健康志愿者中的药代动力学、生物等效性及安全性研究
Huan Song,Yujun Chen,Lianlian Chen et al.
Huan Song et al.
To investigate the pharmacokinetic characteristics of bromocriptine mesylate tablets in healthy Chinese subjects and to assess their bioequivalence and safety. A randomized, open-label, single-dose, four-period, two-sequence, complete cross...
The Pathway to Proof-of-Concept for BNC210, a Negative Allosteric Modulator of the Alpha-7 Nicotinic Acetylcholine Receptor (nAChR), for Treatment of Psychiatric Disease [0.03%]
BNC210作为一种阿尔法-7烟碱乙酰胆碱受体(NACC)拮抗剂治疗精神疾病的实验验证路径研究
Paul Rolan,Elizabeth Doolin,Dharam Paul et al.
Paul Rolan et al.
BNC210 is an investigational small molecule selective negative allosteric modulator of the alpha-7 nicotinic acetylcholine receptor (α7 nAChR). It is an anxiolytic compound with a novel mechanism of action. In a series of Phase 1 clinical ...
A multipart phase 1 study of the safety, pharmacodynamics and pharmacokinetics of ALG-055009, a novel thyroid hormone receptor beta (THR-β) agonist for metabolic dysfunction-associated steatohepatitis (MASH), in healthy participants [0.03%]
ALG-055009的I期多部分研究：这是一种新型甲状腺激素受体β（THR-β）激动剂，用于代谢功能障碍相关肝硬化（MASH），该研究评估了健康参与者中的安全性、药理动力学和药代动力学
Hakim Charfi,Benedetta Massetto,Megan Fitzgerald et al.
Hakim Charfi et al.
ALG-055009 is an oral thyroid hormone receptor beta (THR-β) agonist being evaluated for treating metabolic dysfunction-associated steatohepatitis (MASH). This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics...