Trials / Completed
CompletedNCT00796224
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 6 Months – 11 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2009-02-01
- Completion
- 2009-02-01
- First posted
- 2008-11-24
- Last updated
- 2010-02-18
- Results posted
- 2010-01-25
Locations
2 sites across 1 country: Costa Rica
Source: ClinicalTrials.gov record NCT00796224. Inclusion in this directory is not an endorsement.