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

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Citation

Gropper S, Albareda N, Santos B, Febbraro S

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

Future Microbiol. 2014;9(8 Suppl):S11-6. doi: 10.2217/fmb.14.82.

PubMed ID
25209519 [ View in PubMed
]
Abstract

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.

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