drugset / Trial / NCT00796224
Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2008-12
- Primary completion
- 2009-02
- Completion
- 2009-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azithromycin | Small molecule | 30 mg/kg | Oral |
| Comparator | Azithromycin | Small molecule | 60 mg/kg | Oral |