Conditions: Acute Otitis Media
Keywords: azithromycin, pharmacokinetics, pediatrics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 38
Healthy volunteers: no

Brief summary:
The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive.

Detailed description:

Arms:
arm 1: 60 mg/kg azithromycin ER (Extended Release)arm arm 2: 30 mg/kg azithromycin IR (Immediate Release) arm

Interventions: intervention 1: 60 mg/kg azithromycin ER intervention 2: 30 mg/kg azithromycin IR
Intervention descriptions: intervention 1: subjects taken 60 mg/kg azithromycin ER intervention 2: subjects taken 30 mg/kg azithromycin IR (Immediate Release)

Protocol document: