Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media

A Open Label, Randomized, Single Dose, Parallel Arm Study To Determine Pharmacokinetics Of Azithromycin Following Oral Administration Of Immediate-Release Or Extended-Release Formulation In Pediatric Subjects With Acute Otitis Media

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.

Inclusion Criteria:

• Subjects age 6 months to < 12 years.
• Have clinical signs/symptoms of acute otitis media in at least one ear.
• Parent(s)/legal guardian(s) provide written informed consent.

Exclusion Criteria:

• Clinical significant other disease.
• Recent use of investigational drugs, prescription or nonprescription drugs.