NCT00796224CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1.
Active Comparator
60 mg/kg azithromycin ER (Extended Release)arm
Intervention: 60 mg/kg azithromycin ER (Drug)
2.
Active Comparator
30 mg/kg azithromycin IR (Immediate Release) arm
Intervention: 30 mg/kg azithromycin IR (Drug)
Outcomes
Primary Outcomes
Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)
Time Frame: Predose/0 to 72 Hours
AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.
Secondary Outcomes
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)(Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose)
- Maximum Observed Plasma Concentration (Cmax) of Azithromycin(Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin(Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose)
- Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)(1,2,3,4,8,24,48,72 hours postdose)
- Number of Participants With a Clinical Response(Days 7,8,9 or 10)
- Adverse Events (AEs) and Serious AEs (SAEs)(Baseline up to 28 days)
Investigators
Study Sites (1)
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