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
Chemistry, Medicinal
Lei Sheng, Wei Cao, Pingping Lin, Weili Chen, Hongrong Xu, Chunjiu Zhong, Fei Yuan, Hanjing Chen, Hui Li, Chao Liu, Mengjie Yang, Xuening Li
Summary: The safety, tolerability, and pharmacokinetics of benfotiamine were evaluated in healthy subjects through single and multiple ascending doses. The results showed that benfotiamine was safe and well-tolerated, with moderate accumulation observed for TM and TDP with repeated administration.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
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
Chemistry, Medicinal
Xuemei He, Xin Gao, Panpan Xie, Yuan Liu, Wenjing Bai, Yue Liu, Aixin Shi
Summary: This study assessed the pharmacokinetic and pharmacodynamic profiles, safety, and tolerability of sotagliflozin in Chinese healthy subjects. The results showed that sotagliflozin was rapidly absorbed with dose-proportional systemic exposure and a moderate degree of accumulation. Both 200mg and 400mg doses of sotagliflozin per day were well tolerated in Chinese healthy subjects.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2022)
Article
Chemistry, Medicinal
Qiuying Li, Lihui Jia, Wenli Hu, Shu Dong, Chaohong Cai
Summary: The study evaluated the bioequivalence and safety of two formulations of 25 mg tenofovir alafenamide tablets in Chinese healthy male and female subjects under fed and fasting conditions. The results showed that both formulations met the bioequivalence acceptance criteria and were well tolerated by the subjects, demonstrating bioequivalence in pharmacokinetic parameters under different feeding conditions.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
Article
Plant Sciences
Ruihua Dong, Lijun Li, Hongzhi Gao, Kun Lou, Hongmei Luo, Sheng Hao, Jing Yuan, Zeyuan Liu
Summary: Scutellaria baicalensis (Huang-Qin in Chinese) is an herb high in flavonoids, with baicalein being the most abundant flavonoid. This study evaluated the safety and pharmacokinetic characteristics of baicalein in vivo, showing that baicalein tablets within the studied dose range were safe and well-tolerated in healthy Chinese subjects. Further research is needed to assess safety and efficacy in target patients.
JOURNAL OF ETHNOPHARMACOLOGY
(2021)
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
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
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
Infectious Diseases
Andrea Francesco Daniele Di Stefano, Milko Massimiliano Radicioni, Angelo Vaccani, Alessandro Mazzetti, Luigi Maria Longo, Luigi Moro
Summary: The study aimed to investigate the pharmacokinetic profile of rifamycin SV in plasma and urine in healthy individuals. Results showed negligible systemic absorption of rifamycin SV after oral administration, with plasma concentrations paralleling urine excretion. This supports the development of new rifamycin SV tablets for the treatment of intestinal pathologies.
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)
Article
Microbiology
Mary Beth Wire, Soo Youn Jun, In-Jin Jang, Seung-Hwan Lee, Jun Gi Hwang, David B. Huang
Summary: This study randomized 32 healthy male subjects into different cohorts to evaluate the safety and tolerability of the antistaphylococcal lysin LSVT-1701. Exposure to LSVT-1701 increased in a dose-proportional manner and did not accumulate. The treatment-emergent adverse events were mostly mild, with the most common being chills and fever.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2022)
Article
Pharmacology & Pharmacy
Xiaojiao Li, Lei Gao, Jingrui Liu, Hong Zhang, Hong Chen, Lizi Yang, Min Wu, Cuiyun Li, Xiaoxue Zhu, Yanhua Ding, Li Sun
Summary: HEC30654, a selective 5-HT6 receptor antagonist, was found to be safe and well-tolerated in healthy Chinese subjects at single doses up to 30 mg, with potential therapeutic benefits for cognitive disorders based on preclinical efficacy.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Integrative & Complementary Medicine
Geng Qi-Shun, Liu Rui-Juan, Shen Zhi-Bo, Wei Qian, Zheng Yuan-Yuan, Jia Lan-Qi, Wang Long-Hao, Li Li-Feng, Li Jun, Xue Wen-Hua
Summary: This study explored the underlying mechanism of Shuanghua Baihe Tablet (SBT) in the treatment of oral mucositis (OM) using transcriptomics and metabolomics. The results showed that SBT significantly alleviated symptoms of OM in rats, reduced inflammatory related metabolic pathways, and inhibited IL-17/TNF signal transduction to restore Treg and Th17 cell balance.
CHINESE JOURNAL OF NATURAL MEDICINES
(2021)
Article
Microbiology
Guolan Wu, Huili Zhou, Jing Wu, Duo Lv, Lihua Wu, You Zhai, Meihua Lin, Jingzi J. Wu, Jianzhong Shentu
Summary: This study evaluated the pharmacokinetics and safety of Ravidasvir in healthy adults, as well as its drug-drug interactions with ritonavir-boosted Danoprevir. Results showed dose-proportional increase in RDV exposure after single dose and no accumulation with multiple doses. Co-administration with DNVr resulted in increased plasma concentrations of both RDV and DNV, with no significant changes in ritonavir exposure. Both single and multiple doses of RDV, with or without DNVr, were well tolerated.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2021)