Overview

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

Status:
Terminated
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis externa.
Phase:
Phase 3
Details
Lead Sponsor:
Par Pharmaceutical, Inc.
Collaborator:
Novum Pharmaceutical Research Services
Treatments:
BB 1101
Ciprofloxacin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate