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Type: Artigo de periódico
Title: Phase I Study Of The Novel Antifungal Agent Dapaconazole (zilt®) In Healthy Volunteers
Author: Gagliano-Juca T.
Arruda A.
Sampaio M.F.
Lopes A.G.
De Nucci G.
Abstract: The study aims to evaluate the tolerability of multiple-dose topical dapaconazole tosylate, a new imidazole antiftmgal drug, in healthy vohmteers. Twenty-four healthy vohmteers (12 men) with skin pigmentation classified as I-III in the Fitzpatrick scale emolled 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 occwred 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 vohmteers had dermatological reactions to the formulations. Only one blood sample had detectable levels of dapaconazole (0.23 ng mL-1). One volunteer presented hypertriglyceridemia
Editor: Asian Network for Scientific Information
Rights: fechado
Identifier DOI: 10.3923/ijp.2014.507.512
Date Issue: 2014
Appears in Collections:Unicamp - Artigos e Outros Documentos

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