This is an open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Approximately 3 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 2 to 5 years, 11 months.
Approximately 4 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 6 to 11 years, 11 months.
Merz Investigative Site#001261
College Station, Texas, United States
Merz Investigative Site#180001
Santo Domingo, Dominican Republic
Merz Investigative Site #504001
San Pedro Sula, Honduras
To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis
AUC0-24, Cmax, AUC0-24/D, Cmax/D, AUCt,ss, Cmax,ss, AUCt,,ss/D, Cmax,ss/D
Time frame: 2 weeks
Evaluate plasma PK single and multiple dose PK variables
tmax and tmax,ss
Time frame: 2 weeks
Evaluate trough plasma PK concentration
Ctrough, ttrough,max, Ctrough,max
Time frame: 2 weeks
Evaluate urine PK single and multiple dose variables
Ae0-24, fe, CLR, AEt,ss
Time frame: 2 weeks
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