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Reversal of Opioid-Induced Respiratory Depression in Healthy Volunteers: Comparison of Intranasal Nalmefene and Intranasal Naloxone
J Clin Pharmacol. 2024 Mar 4. doi: 10.1002/jcph.2421. Online ahead of print.ABSTRACTAn open-label, randomized, crossover study in healthy volunteers compared the reversal of remifentanil-induced respiratory depression by intranasal (IN) naloxone hydrochloride (4 mg) to IN nalmefene (2.7 mg) (NCT04828005). Subjects were administered a hypercapnic gas mixture which produces an elevation in minute ventilation (MV), a result of the ventilatory response to hypercapnia. Subjects breathed a hypercapnic gas mixture through a tight-fitting mask for an initial period of 46 min prior to a series of mask "holidays" introduced to reduc...
Source: The Journal of Clinical Pharmacology - March 4, 2024 Category: Drugs & Pharmacology Authors: Mark Ellison Emily Hutton Lynn Webster Phil Skolnick Source Type: research

Changing Trajectories of Alanine Aminotransferase and Risk of Antituberculosis Drug-Induced Liver Injury in Chinese Patients: A Cohort Study
J Clin Pharmacol. 2024 Mar 4. doi: 10.1002/jcph.2422. Online ahead of print.ABSTRACTAntituberculosis drug-induced liver injury (ATLI) is a major adverse effect during antituberculosis treatment. Early detection or prediction is essential to prevent ATLI in antituberculosis treatment patients. The purpose of this work is to explore the relationship between alanine aminotransferase (ALT) trajectories within 15 days of initial treatment and the risk of ATLI. Based on a historical cohort of patients hospitalized for antituberculosis treatment and group-based trajectory modeling analysis, ALT trajectories within 15 days of init...
Source: The Journal of Clinical Pharmacology - March 4, 2024 Category: Drugs & Pharmacology Authors: Xinyu Chen Hongqiu Pan Zhuolu Hao Honggang Yi Shaowen Tang Source Type: research

Pharmacokinetic and Pharmacodynamic Modeling Analysis of Delpazolid (LCB01-0371) in Adult Patients with Pulmonary Tuberculosis
In this study, we evaluated the pharmacokinetics (PK) and pharmacodynamics (PD) of delpazolid after 14 days of multiple oral administration, using data from adult patients with pulmonary tuberculosis. 800 mg once a day, 400 mg twice a day, 800 mg twice a day, and 1200 mg once a day delpazolid for 14 days were tested in 63 patients with pulmonary tuberculosis. For PK blood collection, inpatient and outpatient scheduling were separately implemented. Plasma concentrations of delpazolid were measured at visits 2, 4, 6, and 8 in outpatients, and four sparse blood samples were measured in inpatients. PD models were sequentially ...
Source: The Journal of Clinical Pharmacology - March 4, 2024 Category: Drugs & Pharmacology Authors: Sang Min Lee Seung Chan Choi Kyung Ran Mun Ji Young Seo Young Lag Cho Tae Sun Shim Hyeong-Seok Lim Source Type: research

Breast Milk Excretion of Dinalbuphine Sebacate Injection Administered After Cesarean Section
J Clin Pharmacol. 2024 Mar 1. doi: 10.1002/jcph.2416. Online ahead of print.ABSTRACTEnsuring the safety of analgesics during lactation is crucial for women of childbearing potential. Available data regarding the transfer of nalbuphine for postoperative acute pain via breast milk are limited to the postmarketing experience. This lactation study aimed to assess nalbuphine and dinalbuphine sebacate concentrations in breast milk from lactating women with postoperative pain treated with dinalbuphine sebacate extended-release injection (150 mg dinalbuphine sebacate/2 mL Naldebain). Breast milk was collected throughout the 5-day ...
Source: The Journal of Clinical Pharmacology - March 1, 2024 Category: Drugs & Pharmacology Authors: Sung-Ling Tang Kai-Yi Wang Wen-Kai Hsiao Chi-Kang Lin Source Type: research

Application of Model-Informed Drug Development in Dose Selection and Optimization for siRNA Therapies
In conclusion, the integration of MIDD offers substantial advantages in navigating the complex challenges of dose selection and optimization in siRNA drug development, which in turn accelerates the development process, supports regulatory decision making, and ultimately improves the clinical outcomes of siRNA-based therapies, fostering advancements in precision medicine across a diverse range of diseases.PMID:38426370 | DOI:10.1002/jcph.2418 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - March 1, 2024 Category: Drugs & Pharmacology Authors: Ye Yuan Liang Li Justin Earp Lian Ma Venkatesh Atul Bhattaram Vishnu Sharma Alexander Tong Yaning Wang Jiang Liu Hao Zhu Source Type: research

Effect of Age, Comedications, and CYP3A4/5 Polymorphisms on Perampanel Exposure in Chinese Pediatric Patients With Epilepsy
J Clin Pharmacol. 2024 Feb 21. doi: 10.1002/jcph.2415. Online ahead of print.ABSTRACTPerampanel (PER) is a new type of antiseizure medication used for partial or generalized seizures. However, the plasma concentration shows obvious individual variability in children. The present study aims to ascertain the effect of age, comedications, and cytochrome P450 (CYP) 3A4/5 polymorphisms on PER exposure in Chinese pediatric patients with epilepsy. Clinical data were retrospectively collected in a tertiary children's hospital medical records system from January 2021 to December 2022. The influence factors on the daily dose, plasma...
Source: The Journal of Clinical Pharmacology - February 21, 2024 Category: Drugs & Pharmacology Authors: Huijuan Wang Junyan Wang Bin Lin Huifen Zhang Yangyang Sun Yuanyuan Wu Weifeng Ye Jing Miao Source Type: research