A phase I clinical trial with gadodiamide injection, a nonionic magnetic resonance imaging enhancement agent
| Autor: | P. Leese, O'Toole M, Dilip Worah, Steven C. Quay, VanWagoner M |
|---|---|
| Rok vydání: | 1991 |
| Předmět: |
Adult
Gadolinium DTPA Male medicine.medical_specialty Lightheadedness Dose Phases of clinical research Contrast Media Urine Pharmacokinetics medicine Organometallic Compounds Humans Radiology Nuclear Medicine and imaging Adverse effect medicine.diagnostic_test Dose-Response Relationship Drug business.industry Gadodiamide General Medicine Drug Tolerance Pentetic Acid Magnetic Resonance Imaging Anesthesia Injections Intravenous Serum iron Drug Evaluation Radiology medicine.symptom business medicine.drug |
| Zdroj: | Investigative radiology. 26(11) |
| ISSN: | 0020-9996 |
| Popis: | Twenty adult male volunteers were studied in an unblinded, ascending-dose study to evaluate the safety, tolerance, and pharmacokinetics of intravenously administered nonionic gadodiamide injection. Dosages administered were 0.05, 0.1, 0.2, and 0.3 mmol/kg. Subjects were monitored from 36 hours before, through 72 hours after administration. There were no clinically relevant changes in vital signs or electrocardiograms. No clinically significant changes occurred in blood or urine laboratory parameters, although a tendency for minor, transient elevations in serum iron levels 8 to 48 hours after administration was noted. These changes were not dose-related. Nine of 20 subjects reported at least one adverse event; all events were transient and of mild intensity, the most common being dizziness/lightheadedness and perversion of taste or smell. One subject reported discomfort consisting of mild stinging at the injection site during administration. Gadodiamide was excreted unmetabolized in the urine with greater than 95% recovery at 72 hours after administration. The serum elimination half-life was approximately 70 minutes. |
| Databáze: | OpenAIRE |
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