Systemic bioavailability, safety and tolerability of topical ozenoxacin in healthy adult volunteers.
Future Microbiol
; 9(8 Suppl): S11-6, 2014.
Article
em En
| MEDLINE
| ID: mdl-25209519
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.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Pele
/
Quinolonas
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Aminopiridinas
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Antibacterianos
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Adult
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2014
Tipo de documento:
Article