title: Systemic bioavailability, safety and tolerability of topical ozenoxacin in healthy adult volunteers.
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.
authors.affiliation: Ferrer Internacional SA, Av. Diagonal 549, 5th Floor, 08029 Barcelona, Spain.
authors.forename: Savion
authors.initials: S
authors.lastname: Gropper
authors.forename: Nuria
authors.initials: N
authors.lastname: Albareda
authors.forename: Benjamin
authors.initials: B
authors.lastname: Santos
authors.forename: Salvatore
authors.initials: S
authors.lastname: Febbraro
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000631:Aminopyridines / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D001682:Biological Availability; D004361:Drug Tolerance; D006801:Humans; D008297:Male; D008875:Middle Aged; D015363:Quinolones / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D012867:Skin / Q000187:drug effects*; D014838:Volunteers; D055815:Young Adult
chemical_list: D000631:Aminopyridines; D000900:Anti-Bacterial Agents; D015363:Quinolones; C000592413:ozenoxacin
keywords: Phase I studies; healthy volunteers; ozenoxacin; safety; tolerability