Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

• Naftifine hydrochloride pharmacokinetics variables, single and multiple dose [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]

  Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:

  • Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), calculated using the linear trapezoid rule.
  • Maximum observed plasma concentration (Cmax); the highest plasma concentration in each subject after single dose.

  Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:

  • Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state .
  • Maximum observed plasma concentration (Cmax); the highest plasma concentration in each subject at steady state
  
  

• Efficacy variables [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

  " Efficacy variables to be analyzed after 2 weeks of once daily application of both products ( NAFT-500 or NAFT-600 ) Efficacy variables to be analyzed

  • Complete cure
  • Treatment effectiveness
  • Mycological cure
  • Clinical success
  • Clinical cure
  • Subject satisfaction
  
  
• Time of maximum naftifine plasma concentration after single dose and steady state multiple dose. [ Time Frame: Day 1 and day 14 ] [ Designated as safety issue: No ]

  Variables will be derived from naftifine plasma concentration at predetermined timepoints.

  Trough naftifine plasma concentration variables:

  • Trough plasma concentrations
  • Time (days) to maximal trough plasma concentration
  • Maximum observed trough plasma concentration; the highest trough plasma concentration in each subject
  
  
• Naftifine hydrochloride pharmacokinetic variables in Urine, single dose and multiple dose [ Time Frame: Day 1 and day 14 ] [ Designated as safety issue: No ]

  Variables will be derived from naftifine urine concentration at predetermined timepoints day 1 and day 14. Variables to be analyzed:

  • Partial amount of unchanged drug excreted into urine within the first 24 hours after single dose
  • Fraction of administrated drug excreted into urine (%)
  • Renal clearance

  After multiple doses

  • Amount of unchanged drug excreted into urine during a dosing interval at steady state
  • Fraction of administrated drug excreted into urine during a dosing interval at steady state
  • Renal clearance
  
  

Study population, diagnosis, and main criteria for inclusion:

Tinea pedis and Tinea cruris (NAFT-500):

Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis and Tinea cruris infections confirmed by a positive KOH analysis from both the feet and bikini area. Both cases (feet and bikini area) must be characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional, approximately 4 PK evaluable adult subjects with the same condition will serve as a control.

Tinea pedis (NAFT-600):

Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis infection confirmed by a positive KOH analysis from both feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4 PK evaluable adult subjects with the same condition will serve as a control.