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

NCT00796224 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2010-02-18

Study results available
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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.

Conditions

  • Acute Otitis Media

Interventions

DRUG

60 mg/kg azithromycin ER

subjects taken 60 mg/kg azithromycin ER

DRUG

30 mg/kg azithromycin IR

subjects taken 30 mg/kg azithromycin IR (Immediate Release)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • Costa Rica

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00796224 on ClinicalTrials.gov