Abstract
HOC-155 Cream is a topical antifungal formulation containing the imidazole derivative, omoconazole nitrate. The pharmacokinetics and safety of HOC-155 Cream wereexamined as a part of a phase I study in healthy male volunteers aged 24 to 28 years. Weapplied 5 g of 1 % HOC-155 Cream in a single dose on the skin of the subiects' back over24 hours. No effect attributable to HOC-155 Cream was observed in either the physicalexamination or -the laboratory tests during the period of the study. The average percutaneous absorption rate of HOC-155 Cream over 24 hours was found to be 13.6 % of thedose applied on the skin. Neither omoconazole nitrate nor its principal metabolite (M1) was detected using GC-MS assay in serum samples taken from all subjects studied for144 hours after the application of HOC-155 Cream. Less than 0.1 % of the omoconazolenitrate applied was excreted in the urine, mostly as a conjugated form of M1 withglucuronic acid. We concluded that the safety of HOC-155 Cream is confirmed under thepresent study conditions and that the degree of percutaneous absorption of HOC-155Cream is almost the same as that of other topical antifungal agents reported.
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Schedule a callMore From: Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
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