Comparative Pharmacokinetics and Bioequivalence Assessment of Metformin/Pioglitazone Tablet in Fasting and Fed Conditions: A Randomized Study in Healthy Chinese Subjects [0.03%]
二甲双胍/吡格列酮片空腹与餐后条件下药动学及生物等效性随机试验研究（健康中国受试者）
Hongcheng Li,Mengke Li,Bin Liu et al.
Hongcheng Li et al.
Metformin/pioglitazone tablets are a fixed-dose combination of metformin hydrochloride and pioglitazone. In healthy Chinese subjects, this study evaluated the pharmacokinetics and bioequivalence of metformin/pioglitazone (500/15 mg) tablets...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 May;15(5):e70063. DOI:10.1002/cpdd.70063 2026
Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Luseogliflozin (TS-071) in Japanese Children and Adolescents With Type 2 Diabetes: A Multicenter, Open-Label, Parallel-Group Phase 1 Study [0.03%]
用于治疗2型糖尿病的日籍儿童和青少年单次服用鲁司锂酮（TS-071）的药代动力学、药效学及安全性：一项多中心开放标签平行组Ⅰ期临床试验
Toru Kikuchi,Hidefumi Nakamura,Hideo Umeuchi et al.
Toru Kikuchi et al.
This study aimed to evaluate the pharmacokinetics, pharmacodynamics, and safety of a single dose of luseogliflozin (TS-071), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, in Japanese children and adolescents with type 2 diabetes, with...
Effects of Cedirogant on the Pharmacokinetics of Sensitive Cytochrome P450 Probe Substrates [0.03%]
柴胡香豆素对敏感细胞色素P450探针底物药代动力学的影响
Ronilda D&#x;Cunha,Yuli Qian,Shuai Hao et al.
Ronilda D&#x;Cunha et al.
This study aimed to characterize the effects of cedirogant, an inverse agonist of retinoic acid-related orphan receptor gamma thymus (RORγt), on activities of cytochrome P450 (CYP) enzymes in healthy adults. Twenty study participants recei...
Bioequivalence and Safety Assessment of Brivaracetam Dry Syrup Compared With Tablets in Healthy Japanese Participants: Results From Two Randomized Single- and Multiple-Dose Trials [0.03%]
comparison with tablets in healthy Japanese participants: results from two randomized single- and multiple-dose trials
Yoshinobu Hayakawa,Ryoji Yoshinaka,Tomonobu Sano et al.
Yoshinobu Hayakawa et al.
The antiseizure medication brivaracetam is available as tablets, oral solution, and solution for intravenous injection in many countries. A dry syrup formulation is being developed for use in Japan. We report two phase 1, single-center, ope...
Pharmacokinetics, Bioequivalence, and Safety Evaluation of Two Voriconazole Tablets in Healthy Chinese Volunteers [0.03%]
中国健康志愿者中两种伏立康唑片的药代动力学、生物等效性及安全性评价
Pan Luo,Yongfang Lei,Chang Liu et al.
Pan Luo et al.
Voriconazole is a broad-spectrum antifungal agent belonging to the triazole class, exhibiting significant efficacy against a diverse array of pathogenic organisms. This study aimed to assess the pharmacokinetic properties, bioequivalence, a...
A Randomized, Double-Blinded, Placebo-Controlled QTc Study to Evaluate BIA 28-6156 Effect on Cardiac Repolarization in Healthy Volunteers [0.03%]
评估BIA 28-6156对健康受试者心脏复极化影响的QTc随机双盲安慰剂对照研究
Isa Peixoto,Dana Hilt,Teresa Carvalho et al.
Isa Peixoto et al.
Mutations in the GBA1 gene, encoding beta-glucocerebrosidase (GCase), are the most common genetic risk factor for Parkinson's Disease (PD). BIA 28-6156, an allosteric activator of GCase, is under development for the treatment of GBA-associa...
Steady-State Pharmacokinetic Properties of TNX-102 SL, a Sublingual Tablet Formulation of Cyclobenzaprine Hydrochloride (HCl), With Daily Dosing in Healthy Volunteers: A Randomized, Open-Label Trial [0.03%]
一种环苯扎林盐酸盐颊下片剂（TNX-102 SL）在健康志愿者中每日给药的稳态药代动力学属性：一项随机开放标记试验
Gregory M Sullivan,Bernd Meibohm,Errol Gould et al.
Gregory M Sullivan et al.
This single-center, open-label, randomized, multiple-dose, pharmacokinetic bridging study was conducted to compare systemic exposure (AUC and Cmax) of a sublingual tablet formulation of cyclobenzaprine hydrochloride (TNX-102 SL, approved as...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Apr;15(4):e70060. DOI:10.1002/cpdd.70060 2026
Single-Dose Bioequivalence Study of Elagolix Tablets 200 mg (Test Product) and Elagolix Tablets 200 mg (Reference Product) in Healthy Non-Pregnant, Non-Lactating Premenopausal Female Subjects Under Fasting Conditions [0.03%]
一项单次给药生物等效性研究：在空腹条件下，健康非孕、非哺乳绝经前女性受试者中200毫克Elagolix片剂（试验制剂）和200毫克Elagolix片剂（参比制剂）的生物等效性研究
Sudershan Kumar,Arshad Khuroo,Reshma Quadros et al.
Sudershan Kumar et al.
Elagolix is a short-acting oral gonadotropin-releasing hormone antagonist utilized for treating endometriosis-associated pain by rapidly suppressing gonadotropins and estradiol. Although well characterized in Western populations, clinical d...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Apr;15(4):e70053. DOI:10.1002/cpdd.70053 2026
Thorough QT Study on the Effect of Therapeutic and Supratherapeutic Dosing of Givinostat in Healthy Volunteers [0.03%]
格拉诺司特健康志愿者受试者群体的彻底QT研究（治疗剂量和超大治疗剂量）
Eugenio Mercuri,Barry Byrne,Tracey Willis et al.
Eugenio Mercuri et al.
Givinostat is a class I/II histone deacetylase inhibitor indicated for Duchenne muscular dystrophy (DMD). The study evaluated the effect of therapeutic and supratherapeutic givinostat doses on the QT/QTc interval. Healthy volunteers receive...
Randomized Controlled Trial
Clinical pharmacology in drug development. 2026 Mar;15(3):e70047. DOI:10.1002/cpdd.70047 2026