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International Journal of Pharmacology
Year: 2014  |  Volume: 10  |  Issue: 8  |  Page No.: 507 - 512

Phase I Study of the Novel Antifungal Agent Dapaconazole (Zilt®) in Healthy Volunteers

T. Gagliano-Juca, A.M.M. Arruda, M.F. Sampaio, A.G. Lopes and G. De Nucci    

Abstract: The study aims to evaluate the tolerability of multiple-dose topical dapaconazole tosylate, a new imidazole antifungal drug, in healthy volunteers. Twenty-four healthy volunteers (12 men) with skin pigmentation classified as I-III in the Fitzpatrick scale enrolled in this open-label, two-treatment study with daily application of 40 mg of dapaconazole for 14 consecutive days. Drug application was monitored by a physician and photographs were taken before and 1 h after application to evaluate possible dermatological reactions. Medical evaluations including physical examination, laboratory tests and electrocardiograms were performed to evaluate possible systemic adverse events. To evaluate systemic dapaconazole absorption blood samples were collected before and 2, 4 and 6 h after products application on the first day of treatment. The same occurred in days 7 and 13, but an extra 24 h sample was collected after application of the products. Dapaconazole plasma levels were measured by high-performance liquid chromatography coupled to tandem mass spectrometry. No volunteers had dermatological reactions to the formulations. Only one blood sample had detectable levels of dapaconazole (0.23 ng mL-1). One volunteer presented hypertriglyceridemia (424 mg dL-1) after the 14 days of treatment. Three months after the last dose triglycerides were back to normal range (151 mg dL-1). Dapaconazole 2% (Zilt®) showed a safe adverse event profile for topical application in daily doses of 40 mg for up to 14 days in healthy individuals.

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