Safety, Tolerability, Pharmacokinetics, Food Effect of Ribitol, and Its Effect on QTcF in Healthy Adults: First-in-Human, Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled Studies [0.03%]
关于里比托利在健康成人受试者中的安全性、耐受性、药代动力学及饮食对其影响和对QTcF的影响：首个临床试验，随机、双盲（申办方不盲）、安慰剂对照研究
Daniel D Gretler,Athiwat Hutchaleelaha,Uma Sinha et al.
Daniel D Gretler et al.
Limb-girdle muscle dystrophy Type R9 (LGMDR9), also known as LGMD Type 2I, is a rare genetic disease caused by partial loss of function of fukutin-related protein (FKRP) enzyme which glycosylates alpha-dystroglycan, thereby stabilizing myoc...
Phase 1 Study of Paltusotine, a Novel Oral Once‑Daily, Nonpeptide Selective Somatostatin Receptor 2 Agonist, in Healthy Japanese Adults [0.03%]
帕鲁斯特丁ine用于健康日本成年人的I期研究：一种新型的一天一次口服、非肽类选择性生长抑素受体2激动剂
Fumio Otsuka,Keiko Hanabara,Seigo Akari et al.
Fumio Otsuka et al.
Paltusotine is a novel, nonpeptide, once-daily oral, selective somatostatin 2 receptor (SST2) agonist. We evaluated the pharmacokinetics, pharmacodynamics, and safety of oral paltusotine in healthy Japanese adults in single‑dose (20, 40, 6...
Bioequivalence of Two Firsekibart Subcutaneous Formulations: A Randomized, Double-Blind, Single-Dose, Parallel-Group Study in Healthy Chinese Participants [0.03%]
两种氟西帕巴注射剂型的生物等效性：一项在中国健康受试者中进行的随机双盲、单次给药、平行组研究
Yehua Xie,Xiao Li,Yushi Chen et al.
Yehua Xie et al.
We evaluated the pharmacokinetic (PK) bioequivalence and safety of a new formulation of firsekibart (solution for injection) compared with firsekibart lyophilized powder for solution. In this randomized, double-blind, parallel-group study, ...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jul;15(7):e70077. DOI:10.1002/cpdd.70077 2026
Pharmacokinetics and Bioequivalence of Tamsulosin Hydrochloride Extended-Release Capsules in Healthy Chinese Volunteers: A Randomized, Open-Label, Crossover Study Under Fasting and Fed Conditions [0.03%]
盐酸坦索罗辛缓释胶囊在中国健康受试者中的药代动力学及餐前餐后服用的生物等效性：随机、开放、交叉试验
Lijie Du,Xiaolu Wang,Yi Zhang et al.
Lijie Du et al.
Tamsulosin hydrochloride is a long-acting, highly selective α1A receptor antagonist, primarily used to treat benign prostatic hyperplasia. It effectively alleviates lower urinary tract symptoms, including dysuria, nocturia, and urgency cau...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jul;15(7):e70078. DOI:10.1002/cpdd.70078 2026
Pharmacokinetics and Bioequivalence Study of Levodopa and Benserazide Tablets in Healthy Chinese Subjects Under Fasting and High-Fat Meal Conditions [0.03%]
空腹及高脂餐对健康受试者体内左旋多巴和benserazide药代动力学和生物等效性研究
Yufei Liang,Yanchao Wang,Rui Shi et al.
Yufei Liang et al.
Levodopa and benserazide tablets (LBTs) are a combined preparation of levodopa (L-DP), a dopamine precursor, and benserazide (BZ), a peripheral dopa decarboxylase inhibitor, used for the treatment of Parkinson's disease, which predominantly...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jul;15(7):e70080. DOI:10.1002/cpdd.70080 2026
Comparative bioavailability of a novel fixed-dose combination of ticagrelor and acetylsalicylic acid [0.03%]
替卡格雷与阿司匹林新型复方制剂的相对生物利用度研究
Susana Tera-Ponce,Perla E Castañeda-Tera,Elva J García-Real et al.
Susana Tera-Ponce et al.
Dual antiplatelet therapy (DAPT) with acetylsalicylic acid (hereafter referred to as ASA) and ticagrelor is the standard of care for secondary prevention for atherothrombotic events, particularly in patients with noncardioembolic cerebrovas...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jul;15(7):e70084. DOI:10.1002/cpdd.70084 2026
Comparison of ABBV-552 Safety and Pharmacokinetics in Healthy Asian and Western Adults [0.03%]
ABBV-552在健康亚洲成人和西方成人中的安全性和药代动力学比较研究
Nick Miles,Brian McNamee,Cindy Zadikoff et al.
Nick Miles et al.
ABBV-552, a positive modulator of synaptic vesicle glycoprotein 2A (SV2A), was under investigation as a treatment for cognitive impairment related to Alzheimer's disease. This Phase 1, multicenter, open-label, parallel cohort study (NCT0568...
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 ...