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Bioequivalence Study of Miglitol Orally Disintegrating Tablets in Healthy Chinese Volunteers Under Fasting Condition Based on Pharmacodynamic and Pharmacokinetic Parameters
AbstractTo investigate the bioequivalence of miglitol orally disintegrating tablets in healthy Chinese volunteers based on pharmacodynamic (PD) and pharmacokinetic (PK) parameters. Additionally, the safety profile was estimated. Two randomized, open-label, single-dose, crossover trials were conducted under fasting conditions. In the PD trial (CTR20191811), 45 healthy volunteers were randomly divided into 3 groups in a 1:1:1 ratio and administered sucrose alone or coadministered with 50  mg of miglitol orally disintegrating tablet test or reference formulation/sucrose. In the PK trial (CTR20191696), 24 healthy volunteers w...
Source: Clinical Pharmacology in Drug Development - June 10, 2023 Category: Drugs & Pharmacology Authors: Ming ‐Xuan Zhao, Jin‐Lian Wu, Li‐Chun Dong, Jing Chen, Feng‐Jia Zhu, Yu‐Xin Fan, Juan Zhang, Xiao‐Ping Zhang, Ping Zhang, Chong‐Jing Yu, Meng‐Di Zhou, Jian‐Chang He Tags: Original Article Source Type: research

Evaluation of the Mass Balance and Metabolic Profile of Futibatinib in Healthy Participants
AbstractFutibatinib, a selective, irreversible fibroblast growth factor receptor 1 –4 inhibitor, was recently approved forFGFR2 rearrangement –positive cholangiocarcinoma. This Phase I study evaluated the mass balance and metabolic profile of14C-futibatinib single oral 20-mg dose in healthy participants (n = 6). Futibatinib was rapidly absorbed; median time to peak drug concentration was 1.0 hours. The mean elimination half-life in plasma was 2.3 hours for futibatinib, and 11.9 hours for total radioactivity. Mean recovery of total radioactivity was 70% of the dose, with 64% recovered in feces and 6% in urine. The major...
Source: Clinical Pharmacology in Drug Development - June 10, 2023 Category: Drugs & Pharmacology Authors: Ikuo Yamamiya, Allen Hunt, Fumiaki Yamashita, Daryl Sonnichsen, Toshiharu Muto, Yaohua He, Karim A. Benhadji Tags: Original Article Source Type: research

Pharmacokinetic and Safety Study of Single and Multiple Oral Doses of Safinamide in Healthy Chinese Volunteers
AbstractThis randomized, parallel-group study evaluated the plasma pharmacokinetic profile of safinamide in 24 healthy Chinese men and women, randomly assigned to receive 50 or 100  mg of safinamide as a single dose, followed, after a 7-day washout, by multiple doses once daily for 7 days. Plasma safinamide was determined up to 96 h after the first single dose (day 1) and the last multiple dose (day 14), and up to 24 h after the first multiple dose (day 8). Following single - and multiple-dose administration, peak concentrations were achieved at a median time of 1.5–2 h. Plasma exposure increased in a dose-proportion...
Source: Clinical Pharmacology in Drug Development - June 9, 2023 Category: Drugs & Pharmacology Authors: Sun Jing, Yaozong Yuan, Chiara Leuratti, Valentina Vaja, Carlo Cattaneo Tags: Original Article Source Type: research

Evaluation of Drug –Drug Interaction Potential of Enarodustat (JTZ‐951) Using a Cytochrome P450 Probe Cocktail
AbstractThe drug interaction potential of enarodustat (doses: 25, 50  mg) on the activity of cytochrome P450 (CYP) 1A2, 2C9, 2C19, 2D6, and 3A4 was evaluated after once-daily administration for 15 days in a phase 1 multiple-ascending-dose study in healthy subjects. Probe substrates specific for the enzymes, i.e., caffeine (CYP1A2), tolbutamide (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6), and midazolam (CYP3A4), were administered orally as a cocktail with (day 15) and without (day −3) enarodustat. Drug interaction was based on geometric mean maximum plasma concentration (Cmax) and area under the plasma co...
Source: Clinical Pharmacology in Drug Development - June 3, 2023 Category: Drugs & Pharmacology Authors: Sudhakar M. Pai, Hiroyuki Yamada, Hiroyuki Murata Tags: Original Article Source Type: research

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Source: Clinical Pharmacology in Drug Development - June 1, 2023 Category: Drugs & Pharmacology Tags: Issue Information Source Type: research

Bioequivalence of Celecoxib Capsules in Chinese Healthy Volunteers
This study investigated the pharmacokinetics, safety, and bioequivalence of a single oral dose of celecoxib capsule (the test or reference preparation) in healthy volunteers under fasting and fed conditions. A single-center, randomized, open, single-dose, double-cycle crossover self-control design was conducted: 40 healthy volunteers were enrolled in the fasting and fed groups, respectively. A completely randomized method was used, with one group taking the test celecoxib preparation (T) and the other taking the reference celecoxib preparation (R). During the administration period, the safety of the drug was evaluated simu...
Source: Clinical Pharmacology in Drug Development - May 30, 2023 Category: Drugs & Pharmacology Authors: Lichun Dong, Mingxuan Zhao, Huiyuan Huang, Runfang Guan, Ruixia Li, Yuxin Fan, Jin Feng, Juan Zhang, Wenhong Zou, Jiong Chen, Shuxian Long, Jianchang He Tags: Original Article Source Type: research

Pharmacokinetics of Nifedipine ‐Sustained Release Tablets in Healthy Subjects After a Single Oral Administration: Bioequivalence Analysis and Food Effects
AbstractWe compared newly developed delayed-release oral tablets (test) of 30-mg nifedipine (NFP) with its marketed counterpart (30  mg; reference) in healthy adult Chinese volunteers to assess the former's bioequivalence. This was a randomized, open-label, four-period, crossover trial study including fasting and fed trials. The participants were randomly administered test or reference formulations (1:1 ratio) throughout each period, with a 7-day washout period. In the next session, they were administered the alternate products. Liquid chromatography–tandem mass spectrometry and WinNonlin software were used to evaluate...
Source: Clinical Pharmacology in Drug Development - May 28, 2023 Category: Drugs & Pharmacology Authors: You ‐Xuan Wu, Xue‐Feng Zhong, Xiao‐Min Li, Wan‐Li Liu, Yan‐Xin Zhang, Qiu‐Ying Shen, Su‐Mei Xu, Ping‐Sheng Xu Tags: Original Article Source Type: research

The Pharmacokinetics and Bioequivalence of Desvenlafaxine Succinate in Chinese Healthy Subjects Under Fasting and Fed States
The objective of this study was to evaluate the pharmacokine tics and bioequivalence of desvenlafaxine succinate in Chinese healthy subjects. A single-dose, open-label, randomized, two-way crossover study with a 7-day washout period was conducted. A total of 88 individuals were incorporated to show bioequivalence of a generic and a reference drug, with 48 ind ividuals in the fasting state and 40 receiving a high-fat diet. Finally, 46 and 38 individuals completed the fasting and the fed study, respectively. The 90% confidence intervals of the adjusted geometric mean ratios for maximum plasma concentration, area under the co...
Source: Clinical Pharmacology in Drug Development - May 27, 2023 Category: Drugs & Pharmacology Authors: Manman Wang, Yingying Yang, Wei Hu, Yue Wang, Youli Chen, Xueyuan Zhang Tags: Original Article Source Type: research