Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes
Stopped FDA's draft guidance (revised March 2015) provided two options for determining bioequivalence: 1) in-vitro or 2) in-vivo studies
Conditions
- Otitis Media in Patients With Tympanostomy Tubes
Interventions
- DRUG: Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension
- DRUG: CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)
- DRUG: Placebo Sterile Otic Suspension
Sponsor
Par Pharmaceutical, Inc.
Collaborators