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

Condition(s) targeted: Acute Otitis Media

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

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Pfizer

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

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Following a single dose of azithromycin 60 mg/kg extended release formulation, pediatric subjects with acute otitis media will have similar azithromycin AUC compared with subjects taken 30 mg/kg immediate release formulation

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: Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study

Primary outcome: pharmacokinetic parameters AUC72, AUCinf, Cmax, Tmax and t1/2

Secondary outcome:

adverse events monitoring

clinical response

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

Criteria:

Inclusion Criteria:

- Subjects age 6 months to 6 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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

Starting date: January 2009
Ending date: April 2009
Last updated: December 2, 2008