Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis

Condition(s) studied

Investigational drug(s) / intervention(s)

Terbinafine Tablets: Oral administration once daily: For patients weighing \<20 kg: 62.5 mg qd; For patients weighing 20-40 kg: 125 mg qd; For patients weighing \>40 kg: 250 mg qd; Total 8 weeks.

Study summary

The goal of this observational study is to characterize the population pharmacokinetics (PPK) of terbinafine in pediatric patients with tinea capitis, evaluate its efficacy and safety, and identify covariates affecting drug disposition in Chinese children aged 2-18 years diagnosed with tinea capitis and treated with oral terbinafine. The main questions it aims to answer are:

What are the terbinafine pharmacokinetic parameters (e.g., AUC, CL, V) in children with tinea capitis, and how do they differ from adult values? Which covariates (e.g., age, body weight, CYP enzyme activity, renal function) significantly influence inter-individual variability in terbinafine PK parameters? What is the clinical efficacy (based on TSSS reduction and mycological cure rate) and safety profile of terbinafine in this pediatric population?

Participants will:

Undergo oral terbinafine treatment according to weight-based dosing (62.5-250 mg daily).

Concentration determination is carried out using the opportunistic sampling method.

Complete clinical assessments (TSSS scoring) and mycological examinations (microscopy/culture) at baseline and follow-up visits.

Undergo routine laboratory tests (liver/kidney function, hematology) to monitor safety.

Eligibility

Primary outcome measure(s)

• Terbinafine concentration — Through study completion, an average of 12 weeks.
  Terbinafine plasma concentration, terbinafine concentration in hair
• AUC — Through study completion, an average of 12 weeks.
  Area under the curve (AUC)
• CL — Through study completion, an average of 12 weeks.
  Clearance (CL)
• V — Through study completion, an average of 12 weeks.
  Apparent volume of distribution (V)
• CV% — Through study completion, an average of 12 weeks.
  Inter-individual variability (CV%) of AUC, CL and V with covariates

Trial sites (1)

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