Single Dose Pharmacokinetics Of Topical Iodiconazole Creams In Healthy Chinese Volunteers

1.In this study, the pharmacokinetics of new triazole antifungal iodiconzole creams at target sites after single-dose topical application was investigated.2.30 healthy Chinese volunteers were randomly divided into three groups after being stratified by sex, each group was given a single topical dose of 1%, 2%, 4% iodiconazole cream (0.4 g). Stratum corneum (SC) samples of treated sites were collected by tape-stripping method after the chosen contact times, and were extracted and analysed by a validated LC-MS method.3.After single-dose topical application of 1%, 2%, 4% iodiconazole creams, the C-max of iodiconazole in SC was 1.2 +/- 0.7, 2.2 +/- 1.0, 2.4 +/- 1.0 mg/g; T-max was 3.3 +/- 1.1, 2.9 +/- 1.1, 3.8 +/- 0.4 h; t(1/2) was 6.6 +/- 3.4 h, 7.2 +/- 4.1 h, 5.9 +/- 2.9 h; AUC(0-t) was 10.9 +/- 3.0, 20.8 +/- 10.4, 20.9 +/- 7.9 mg center dot h/g; AUC(0-infinity) was 11.6 +/- 2.9, 23.5 +/- 14.4, 22.2 +/- 8.9 mg center dot h/g, respectively. The results showed that C-max, AUC(0-t) and AUC(0-infinity) did not increase proportionately with dose, which could also be due to the drug being saturated in the formulation at similar to 2%.4.The results of this study could provide reference for the clinical medication and further study of the formulations.