دورية أكاديمية
Pharmacokinetics and pharmacodynamics of perfluoropropane after intra-venous bolus injection of perflutren lipid microsphere injection (DEFINITY®) in healthy Chinese volunteers.
العنوان: | Pharmacokinetics and pharmacodynamics of perfluoropropane after intra-venous bolus injection of perflutren lipid microsphere injection (DEFINITY®) in healthy Chinese volunteers. |
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المؤلفون: | Li P; Department of Pharmacy, Beijing An Ding Hospital, Capital Medical University, No.5 Ankang Hutong, Xicheng District, Beijing, 100088, China. lee-pf@163.com.; Phase I Clinical Trial Unit, Beijing Chao-Yang Hospital, Capital Medical University, No.8 Gongti South Road, Chaoyang District, Beijing, 100020, China. lee-pf@163.com., Du P; Phase I Clinical Trial Unit, Beijing Chao-Yang Hospital, Capital Medical University, No.8 Gongti South Road, Chaoyang District, Beijing, 100020, China., Peng J; Guoke Excellence (Beijing) Medicine Technology Research Co., Ltd, No.18 Zhonghe street, Daxing District, Beijing, 100176, China., Zhao Z; Department of Pharmacy, China-Japan Friendship Hospital, No.2 Yinghuayuan East Street, Chaoyang District, Beijing, 100029, China., Li H; Phase I Clinical Trial Unit, Beijing Chao-Yang Hospital, Capital Medical University, No.8 Gongti South Road, Chaoyang District, Beijing, 100020, China., Yu W; Phase I Clinical Trial Unit, Beijing Chao-Yang Hospital, Capital Medical University, No.8 Gongti South Road, Chaoyang District, Beijing, 100020, China., Wang S; Phase I Clinical Trial Unit, Beijing Chao-Yang Hospital, Capital Medical University, No.8 Gongti South Road, Chaoyang District, Beijing, 100020, China. shuminwang7000@163.com., Liu L; Department of Pharmacy, China-Japan Friendship Hospital, No.2 Yinghuayuan East Street, Chaoyang District, Beijing, 100029, China. hong@outlook.com. |
المصدر: | BMC pharmacology & toxicology [BMC Pharmacol Toxicol] 2024 Jan 02; Vol. 25 (1), pp. 6. Date of Electronic Publication: 2024 Jan 02. |
نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't |
اللغة: | English |
بيانات الدورية: | Publisher: BioMed Central Country of Publication: England NLM ID: 101590449 Publication Model: Electronic Cited Medium: Internet ISSN: 2050-6511 (Electronic) Linking ISSN: 20506511 NLM ISO Abbreviation: BMC Pharmacol Toxicol Subsets: MEDLINE |
أسماء مطبوعة: | Original Publication: London : BioMed Central |
مواضيع طبية MeSH: | Volunteers* , Lipids*, Humans ; Male ; Female ; Microspheres ; Area Under Curve ; China ; Healthy Volunteers |
مستخلص: | Background and Objective: Definity is an ultrasound contrast agent consisting of phospholipids-encapsulated perfluoropropane (PFP), also known as perflutren, microspheres, which is initially designed to enhance echocardiographic ultrasound images. With no pharmacologic action, Definity can increase the backscatter of ultrasound resulting enhanced ultrasound signals. The objective of this study was to determine the pharmacokinetics (PKs), Pharmacodynamics (PDs) and safety of Definity in healthy male and female Chinese volunteers. Methods: A simple GC-MS method was developed and applied to simultaneously quantify PFP both in human whole blood and in expired air using Perfluorobutane (PFB) as internal standard. Meanwhile, the blood microbubble Doppler intensities were continuously monitored as companion PDs by a Doppler ultrasonography system using a non-imaging method. Results: After intravenous infusion of 10 µL/kg of PFP within 30 seconds, the mean AUC Conclusion: The pharmacokinetics and pharmacodynamics of Definity in blood and expired air were systematically evaluated for the first time in this study. The PK/PD analysis results of this trial showed that the change of blood concentration was related to the change process of Doppler signal intensity, the trend of the two was close and expired air are the main excretion pathways of Definity. Definity was well tolerated by all subjects in the trial. Trial Registration: This study was registered on 08 December 2017 at the Chinese Clinical Trial Registry (CTR20171087). (© 2024. The Author(s).) |
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معلومات مُعتمدة: | 2020-1-2031 Capital's Funds for Health Improvement and Research |
فهرسة مساهمة: | Keywords: Definity; Doppler ultrasonography; GC-MS; Perfluoropropane (PFP); Pharmacodynamics; Pharmacokinetics |
سلسلة جزيئية: | ChiCTR CTR20171087 |
المشرفين على المادة: | CK0N3WH0SR (perflutren) 0 (Lipids) |
تواريخ الأحداث: | Date Created: 20240103 Date Completed: 20240105 Latest Revision: 20240112 |
رمز التحديث: | 20240113 |
مُعرف محوري في PubMed: | PMC10763448 |
DOI: | 10.1186/s40360-023-00729-z |
PMID: | 38167238 |
قاعدة البيانات: | MEDLINE |
تدمد: | 2050-6511 |
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DOI: | 10.1186/s40360-023-00729-z |