Pharmacokinetic Comparability of ABP 654, a Biosimilar to Ustekinumab, Administered Either via Prefilled Syringe or Autoinjector in Healthy Adults: Results from a Randomized, Open-Label, Parallel-Group Study [0.03%]
一项随机、开放标记、平行组研究结果：在健康成人受试者中，托珠单抗类似药ABP 654通过预装注射器或自身注射器给药的药代动力学可比性
Vincent Chow,Peter J Winkle,Daniel T Mytych et al.
Vincent Chow et al.
ABP 654, a biosimilar to ustekinumab reference product, is available in a prefilled syringe (PFS) for subcutaneous (SC) use. The ABP 654 autoinjector pen (AIP) has recently been developed with an aim to improve the injection experience for ...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Feb;15(2):e70031. DOI:10.1002/cpdd.70031 2026
Kenneth T Moore
Kenneth T Moore
Bioequivalence and Pharmacokinetic Evaluation of Gliclazide Modified-Release Tablets in Healthy Chinese Volunteers [0.03%]
格列齐特缓释片在中国健康受试者中的生物等效性和药代动力学评价研究
Kejia Fu,Chengcan Lu,Yuping Zhang et al.
Kejia Fu et al.
This was a single-center, randomized, open-label, two-formulation, and two-cycle crossover trial conducted in 52 healthy Chinese volunteers, under fasting and fed conditions. The participants received oral doses of the test formulation (gli...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Feb;15(2):e70021. DOI:10.1002/cpdd.70021 2026
A comparative pharmacokinetic evaluation of two aqueous progesterone 25 mg injections in healthy postmenopausal women under fasting conditions: An open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study [0.03%]
一项在空腹健康绝经后女性受试者中比较两种每支25毫克黄体酮注射液型的人体药代动力学研究：开放性、平衡、随机、两制剂、两周期、两序列、单次给药、交叉生物等效性研究报告
Noopur Vyas,Amaresh Chakra,Prashant Sarode et al.
Noopur Vyas et al.
The growing demand for assisted reproductive technology (ART) has increased the need for effective luteal phase support. Progesterone, essential for maintaining early pregnancy, is a critical component of ART. This open-label, balanced, ran...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Feb;15(2):e70025. DOI:10.1002/cpdd.70025 2026
Bioequivalence Evaluation of Two Metformin/Empagliflozin Fixed-Dose Combination Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions: A Randomized, Open-Label, Crossover Study [0.03%]
在空腹及餐后条件下中国健康受试者中两种盐酸二甲双胍恩格列净固定剂量复方片与参比制剂相对生物等效性评价的随机、开放、两周期、两序列交叉试验
Yuyan Lei,Qin Yi,Shan Ji et al.
Yuyan Lei et al.
This study evaluated the bioequivalence and safety of two fixed-dose combination (FDC) tablet formulations of metformin/empagliflozin (1000 mg/5 mg) in healthy Chinese subjects. A single-center, open-label, randomized, two-period, two-treat...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jan;15(1):e70029. DOI:10.1002/cpdd.70029 2026
First-In-Human Study to Assess the Pharmacokinetics and Safety of DS-6016a After Single Subcutaneous Injection in Healthy Japanese Adults [0.03%]
DSI6016A单次皮下注射在中国健康受试者中的药代动力学和安全性首次人体研究
Kei Okita,Hidetoshi Furuie,Akifumi Kurata et al.
Kei Okita et al.
Fibrodysplasia ossificans progressiva is a rare, progressive autosomal dominant genetic disease caused by an activin receptor-like kinase 2 (ALK2) mutation with a need for effective prophylactic therapies. This single-center, randomized, do...
A Human Mass Balance and Metabolism Study of [14C]-Ubrogepant in Healthy Male Adults [0.03%]
乌布鲁冈片在健康成人男性受试者中的放射性碳人体质量平衡及代谢研究
Ramesh R Boinpally,Joshua Rowe,Pushpa Chandrasekar et al.
Ramesh R Boinpally et al.
Ubrogepant is a calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine with or without aura in adults. The mass balance and metabolism of ubrogepant was evaluated in six healthy male adults administ...
Pharmacokinetic Interaction Among Amlodipine, Losartan, and Chlorthalidone after a Single Oral Administration in Healthy Male Subjects [0.03%]
单次口服给药氨氯地平、厄沙坦和氯噻酮的药物相互作用健康男性受试者的药代动力学研究
Seol Ju Moon,Sung Hee Hong,Yirang Lim et al.
Seol Ju Moon et al.
Antihypertensive drugs are more potent when administered in combinations of two or three different classes of drugs. The objective of this study was to evaluate the pharmacokinetic interaction among amlodipine, losartan, and chlorthalidone....
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jan;15(1):e70024. DOI:10.1002/cpdd.70024 2026
Pharmacokinetics, Bioequivalence, and Safety of Diclofenac Sodium Sustained-Release Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions [0.03%]
健康受试者空腹及餐后条件下氯诺昔康钠缓释片的药代动力学、生物等效性及安全性研究
Biao Sun,Li Zhao,Fangliang Gan et al.
Biao Sun et al.
The study aimed to evaluate the pharmacokinetics, bioequivalence, and safety of domestic diclofenac sodium sustained-release tablets (0.1 g) and a reference formulation in healthy Chinese subjects. Two independent trials (fasting and fed co...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jan;15(1):e70019. DOI:10.1002/cpdd.70019 2026
Effect of High-Fat Food on the Pharmacokinetics and Safety of Amlodipine/Benazepril in Healthy Chinese Participants [0.03%]
高脂饮食对健康中国受试者氨氯地平/贝那普利药代动力学和安全性的影响
Congyang Ding,Haojing Song,Bo Qiu et al.
Congyang Ding et al.
This study assessed the effect of high-fat food on pharmacokinetics and safety of amlodipine, benazepril, and benazeprilat in healthy Chinese participants under fasting and fed conditions from a bioequivalence trial. This trial enrolled a t...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Jan;15(1):e70022. DOI:10.1002/cpdd.70022 2026