A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa

NCT01910155 · clinicaltrials.gov ↗

PHASE3

Phase

TERMINATED

Status

455

Enrollment

INDUSTRY

Sponsor class

Stopped FDA's draft guidance (March 2015) provided option of in-vitro or in-vivo studies for bioequivalence. Small study size resulted in negative culture rates.

Conditions

Otitis Externa

Interventions

DRUG: Ciprofloxacin/Dexamethasone
DRUG: Ciprodex (R)
DRUG: Placebo

Sponsor

Par Pharmaceutical, Inc.

Collaborators

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