Article
Infectious Diseases
Massimo Tempestilli, Tommaso Ascoli Bartoli, Domenico Benvenuto, Giulia Valeria Stazi, Luisa Marchioni, Emanuele Nicastri, Chiara Agrati
Summary: This study aimed to investigate the inter-individual variability of remdesivir and its metabolite GS-441524 in COVID-19 inpatients and its associations with demographic/biochemical variables. The results showed a high interpatient variability of remdesivir and GS-441524, likely influenced by age and renal function in COVID-19 inpatients.
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
(2022)
Article
Infectious Diseases
Yaxin Fan, Yi Li, Yuancheng Chen, Jicheng Yu, Xiaofen Liu, Wanzhen Li, Beining Guo, Xin Li, Jingjing Wang, Hailan Wu, Yu Wang, Jiali Hu, Yan Guo, Fupin Hu, Xiaoyong Xu, Guoying Cao, Jufang Wu, Yingyuan Zhang, Jing Zhang, Xiaojie Wu
Summary: This study evaluated the pharmacokinetic/pharmacodynamic profiles and safety of CMS in Chinese subjects following a recommended dosage. The results showed that CMS may be effective against most carbapenem-resistant organisms, but inadequate for some carbapenem-resistant Acinetobacter baumannii.
Article
Pharmacology & Pharmacy
Lei Gao, Qingmei Li, Hong Zhang, Min Wu, Min Fang, Lizhi Yang, Xiaojiao Li, Jingrui Liu, Cuiyun Li, Hong Chen, Xiaoxue Zhu, Yanhua Ding, Mingwei Zhou
Summary: The study confirmed pharmacokinetic biosimilarity between QX001S and ustekinumab, with high variability between subjects.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Endocrinology & Metabolism
Qi Pan, Xiaoxia Wang, Wenjia Li, Xiaofeng Chen, Yulei Zhuang, Qinghong Zhou, Yuhui Huang, Yijie Zhou, Li Lan, Zhijie Wang, Wenjia Wang, Juan Hong, Wei-Hua Hao, Yu-Tsai Yang, Lixin Guo
Summary: This study aimed to verify whether the oral insulin N11005 is used as a prandial insulin by comparing its pharmacokinetics (PK), pharmacodynamics (PD), and safety profiles with a short-acting biosynthetic human insulin (Novolin R). A total of 12 healthy Chinese male subjects were enrolled in the study, and the results showed that N11005 has similar PD characteristics to prandial insulins, with a faster onset of action and comparable duration of action to the reference insulin. The study also demonstrated the safety and tolerability of N11005.
FRONTIERS IN ENDOCRINOLOGY
(2023)
Article
Health Care Sciences & Services
Maria C. Ovejero-Benito, Dolores Ochoa, Teresa Enrique-Benedito, Miriam del Peso-Casado, Pablo Zubiaur, Marcos Navares, Manuel Roman, Francisco Abad-Santos
Summary: This study aimed to identify SNPs associated with the pharmacokinetics, pharmacodynamics, and safety of donepezil and memantine. Through genotyping and statistical analysis, no significant association was found between these SNPs and the pharmacokinetics or ADRs of the drugs. Therefore, current evidence does not support the inclusion of donepezil and memantine in pharmacogenetic guidelines.
JOURNAL OF PERSONALIZED MEDICINE
(2022)
Article
Pharmacology & Pharmacy
Robert Hoerr, Andrea Zimmermann, Friedeborg Seitz, Angelika Dienel
Summary: The study confirmed that both single and repeated doses of EGb 761 (R) do not impact the plasma concentrations of rivaroxaban or anti-Factor Xa activity in healthy subjects, and the treatments are safe and well-tolerated.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Chemistry, Medicinal
Jin Wang, Huan Zhang, Rui Wang, Yun Cai
Summary: In this study, the pharmacokinetics, bioequivalence and safety profiles of 90 mg ticagrelor tablets and their active metabolite were evaluated in healthy Chinese subjects under fasting and fed conditions. The results showed no significant differences in PK parameters and bioequivalence between the test and reference drugs, with no severe adverse events observed.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
Article
Infectious Diseases
Yingying Hu, Qiong Wei, Xingchen Bian, Xinyi Yang, Jicheng Yu, Jingjing Wang, Haijing Yang, Guoying Cao, Xiaojie Wu, Jing Zhang
Summary: This study investigated the pharmacokinetics and safety of oral and intravenous lefamulin in healthy Chinese subjects, and evaluated the efficacy of the intravenous administration regimen. The results showed that lefamulin exhibited extensive distribution, and the PK parameters were consistent between oral and intravenous administration. The regimen was found to be microbiologically effective and well-tolerated.
Article
Chemistry, Medicinal
Wanjun Bai, Haojing Song, Yiting Hu, Xueyuan Zhang, Xiaoru Wang, Caihui Guo, Bo Qiu, Zhanjun Dong
Summary: This study compared the pharmacokinetics and safety of generic and original vortioxetine hydrobromide tablets under fasting and fed conditions. The results showed that the pharmacokinetic parameters of the test drug were similar to those of the reference drug, indicating bioequivalence. Both formulations were safe and well-tolerated in healthy Chinese subjects.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2023)
Article
Health Care Sciences & Services
Carlos Alejandro Diaz-Tufinio, Jose Antonio Palma-Aguirre, Vanessa Gonzalez-Covarrubias
Summary: This study investigated the association between fluoxetine pharmacokinetics (PK) and pharmacogenetic variants. The results revealed that multiple single nucleotide variants (SNVs) on different genes have a quantifiable impact on the PK of fluoxetine. In particular, decreased or non-function SNVs of CYP2D6 and CYP2C19 were confirmed phenotypically.
JOURNAL OF PERSONALIZED MEDICINE
(2023)
Article
Pharmacology & Pharmacy
Sean P. Oosterholt, Oscar Della Pasqua
Summary: Raxibacumab is a fully humanized monoclonal antibody that blocks the interaction of Bacillus anthracis toxins and is approved for the treatment and prophylaxis of inhalational anthrax. Population pharmacokinetic modeling showed that weight was the only influential covariate affecting disposition parameters in healthy subjects receiving a 40 mg/kg IV dose of Raxibacumab.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2021)
Article
Chemistry, Medicinal
Hyewon Chung, Jong-Min Kim, Jin-Woo Park, Jihyeon Noh, Kyoung-Ah Kim, Ji-Young Park
Summary: The aim of this study was to evaluate the effects of simvastatin on the pharmacokinetics and anticoagulant effects of dabigatran etexilate. The results showed that co-administration of simvastatin slightly altered the pharmacokinetic parameters of dabigatran etexilate but had minimal impact on its anticoagulant effects.
Article
Microbiology
David C. Griffith, Elizabeth E. Morgan, Michael N. Dudley, Jeffery S. Loutit
Summary: The study showed that Biapenem exposure increased slightly more than dose proportionally after multiple doses, with no evidence of accumulation. Urinary recovery ranged from 14.2% at 250 mg to 42.3% at 1,250 mg. Biapenem was well tolerated up to 1,000 mg doses every 8 hours, but higher incidences of nausea, vomiting, and rash were reported at 1,250 mg.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2021)
Article
Pharmacology & Pharmacy
Titia Q. Ruijs, Ingrid W. Koopmans, Marieke L. de Kam, Michiel J. van Esdonk, Martin Koltzenburg, Geert Jan Groeneveld, Jules A. A. C. Heuberger
Summary: The aim of this study was to evaluate the detection of drug-induced changes in sodium conductance through peripheral nerve excitability profile. Results showed that mexiletine and lacosamide significantly affected the excitability of motor and sensory nerves, in line with their suggested mechanism of action. This study demonstrated that nerve excitability threshold tracking can be an effective pharmacodynamic biomarker and a valuable tool in clinical drug development.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2022)
Article
Pharmacology & Pharmacy
Hanjing Chen, Weili Chen, Fei Yuan, Qingcheng Guo, Xunmin Zhang, Chenguang Wang, Xuening Li
Summary: This study evaluated the bioequivalence of CMAB807, a biosimilar to denosumab, for the treatment of osteoporosis. The results showed that CMAB807 had similar pharmacokinetics, pharmacodynamics, safety, and immunogenicity to denosumab. CMAB807 could potentially be a new treatment option for patients with osteoporosis.
FRONTIERS IN PHARMACOLOGY
(2022)
