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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Otitis Media

Intervention: 60 mg/kg azithromycin ER (Drug); 30 mg/kg azithromycin IR (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)

Secondary outcome:

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)

Maximum Observed Plasma Concentration (Cmax) of Azithromycin

Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin

Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)

Number of Participants With a Clinical Response

Adverse Events (AEs) and Serious AEs (SAEs)

Eligibility

Minimum age: 6 Months. Maximum age: 11 Years. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, San Jose 0000, Costa Rica

Pfizer Investigational Site, San Jose, Costa Rica

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: December 2008
Last updated: February 1, 2010

Page last updated: August 23, 2015

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