PIO 7706 The potential of perflenapent emulsion, an ultrasound contrast agent, in the management of urinary tract disease
✍ Scribed by JM Correas; O Hélénon; L Menassa; A Méjean; JC Boyer; JF Moreau
- Publisher
- Elsevier Science
- Year
- 1997
- Tongue
- English
- Weight
- 143 KB
- Volume
- 23
- Category
- Article
- ISSN
- 0301-5629
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✦ Synopsis
Purpose: To present clinical pharmacology of Sonovue (BRl) a new contrast medium (CM) for ultrasound imaging. Methods: Ninety-eight healthy volunteers in five single-or repeateddose phase I trials (two placebo-controlled). Sonovue doses from 0.003 (single) to 0.6 mlikg bw (cumulative of three consecutive doses). Efficacy evaluation: improvement of B-mode signal in cardiac and of Doppler signal in extracardiac studies. Safety assessments: adverse events (AEs) and safety parameters (subjective/ physical observations, vital signs, 9 saturation, Halter ECG and echocardiography, Mini-Mental State test, visual acuity, pre-and post-CM laboratory tests) monitored up to 24-72 hours post-dosing. Tolerance evaluated as patient discomfort associated with CM injection. Results: Sonovue always passed through the pulmonary circulation and improved left ventricle endocardibl .border defmition and Doppler signal in different vascular districts. No serious AEs were recorded. The non-serious AEs were transient, mild in intensity and unrelated to CM. No clinically significant changes in safety parameters were observed. Conclusions: Under the conditions tested, Sonovue is a safe and effective CM for ultrasound imaging.