Systemic bioavailability, safety and tolerability of topical ozenoxacin in healthy adult volunteers.

Autor: Gropper, Savion, Albareda, Nuria, Santos, Benjamin, Febbraro, Salvatore
Zdroj: Future Microbiology; Aug2014 Supplement, Vol. 9 Issue 8s, pS11-S16, 6p
Abstrakt: A series of Phase I studies was conducted in healthy volunteers to examine the systemic bioavailability and safety of topical ozenoxacin. Study 1 examined increasing single doses (relating to quantity and body surface area) of ozenoxacin 1% ointment. Study 2 compared multiple doses of ozenoxacin 1% ointment and placebo applied for 7 days. Study 3 investigated multiple doses of ozenoxacin 2% cream and placebo applied for 7 days. Study 4 examined multiple doses of ozenoxacin 2% cream applied to intact and abraded skin for 8 days. No systemic absorption was observed in any study and ozenoxacin was well tolerated. The most common treatment-related adverse events were application-site reactions (erythema and pruritus), but the differences in local tolerability between ozenoxacin and placebo were not clinically significant. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index