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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
subjects taken 60 mg/kg azithromycin ER
subjects taken 30 mg/kg azithromycin IR (Immediate Release)
Pfizer Investigational Site
San José, Provincia de San José, Costa Rica
Pfizer Investigational Site
San José, Provincia de San José, Costa Rica
Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)
AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.
Time frame: Predose/0 to 72 Hours
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)
AUCinf = AUClast + (Clast\* divided by kel), where AUClast is calculated by Linear-Log trapezoidal method, Clast\* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of Azithromycin
Time frame: 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
Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half.
Time frame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose
Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)
Time frame: 1,2,3,4,8,24,48,72 hours postdose
Number of Participants With a Clinical Response
Clinical response was assesed between Days 7 and 10, or when subjects discontinued the study prematurely (if applicable). Response was assessed by the investigator as cure or failure. Cure = Clinical signs and symptoms related to the acute illness have resolved, or clinical improvement is such that no additional therapy is necessary. Failure = One or more of the following: * Signs and symptoms related to the acute illness have persisted or worsened and additional therapy is necessary; * New clinical signs and symptoms of acute illness have developed and additional therapy is necessary
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Time frame: Days 7,8,9 or 10
Adverse Events (AEs) and Serious AEs (SAEs)
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported.
Time frame: Baseline up to 28 days