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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Azithromycin

Criteria

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.