Clinical Phase I Study of OPB-2045, A New Antiseptic III. Investigation of the safety and pharmacokinetic profile of OPB-2045 by repeated applications

The safety and pharmacokinetic profile of OPB-2045 solution, a new monobiguanide antiseptic, were evaluated in 6 healthy adult male subjects who received repeated applications of 0.1% or 0.5% OPB-2045 solution to the flexor region of both forearms twice daily for 5 days. The actual amount of OPB-204...

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Bibliographic Details
Published inSkin research Vol. 41; no. 2; pp. 236 - 242
Main Author Sugai, Tetsuro
Format Journal Article
LanguageEnglish
Published Meeting of Osaka Dermatological Association 1999
Subjects
antiseptic
clinical phase I study
OPB-2045
pharmacokinetic profile
repeated applications
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Summary:The safety and pharmacokinetic profile of OPB-2045 solution, a new monobiguanide antiseptic, were evaluated in 6 healthy adult male subjects who received repeated applications of 0.1% or 0.5% OPB-2045 solution to the flexor region of both forearms twice daily for 5 days. The actual amount of OPB-2045 applied to the skin of each subject was 6 mg/day, accounting for 30 mg over the 5 days. There were no subjective symptoms, objective signs, changes in physiological parameters or resting 12-lead ECG, or abnormal changes in clinical laboratory values. The serum and urine concentrations of unchanged OPB-2045 were below the detection limits at all measurement time points in all subjects. The above results suggest that OPB-2045 has a high degree of safety and is a promising antiseptic for clinical use.
ISSN:0018-1390
1884-541X
DOI:10.11340/skinresearch1959.41.236