Artículos de revistas
Phase I Study Of The Novel Antifungal Agent Dapaconazole (zilt®) In Healthy Volunteers
Registro en:
International Journal Of Pharmacology. Asian Network For Scientific Information, v. 10, n. 8, p. 507 - 512, 2014.
18117775
10.3923/ijp.2014.507.512
2-s2.0-84914144863
Autor
Gagliano-Juca T.
Arruda A.
Sampaio M.F.
Lopes A.G.
De Nucci G.
Institución
Resumen
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 10 8 507 512 Alexandra, J.F., Pautas, E., Gouin-Thibault, I., Siguret, V., Loriot, M.A., Over anticoagulation with cownarin and cutaneous azole therapy (2008) Ann. Internal Me<Checkcomponent>D</Checkcomponent>., 148, pp. 633-635 Ali, S.M., Brodell, R.I., Balkrishnan, R., Feldman, S.R., Poor adherence to treatments: A fundamental principle of dermatology (2007) Arch. Dermatol., 143, pp. 912-915 Botter, A.A., Topical treatment of nail and skin infections with miconazole, a new broad-spectnnn antimycotic (1971) Mykoses, 14, pp. 187-191 Broos, N., Van Puijenbroek, E.P., Interaction between topical miconazole and colllllarins (2010) Eur. J. Clin. Pharmacal., 66, pp. 1171-1172 Plempel. 1972. 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