NCT02466867已完成4 期
An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftin® (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis
研究概览
简要总结
This is an open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or females 2 to 11 years, 11 months of any race. Females of child producing age (started menarche) must have a negative urine pregnancy test.
- •Presence of tinea corporis characterized by clinical evidence of a tinea infection at multiple sites covering a total of at least 1% body surface area.
- •KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected of the overall severity.
- •Subjects must be in good health and free from clinically significant disease that might interfere with the study evaluations.
排除标准
- •Tinea infection of the scalp, face, groin, and/or feet.
- •A life-threatening condition (ex. autoimmune deficiency syndrome, cancer) within the last 6 months
- •Subject with abnormal findings-physically or laboratory- that considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
- •Subjects with a known hypersensitivity or other contradictions to study medications or their components.
研究组 & 干预措施
Naftin® Cream, 2% (younger pediatric cohort)
Experimental
Subject aged 2 years to 5 years, 11 months with tinea corporis
干预措施: Naftin® Cream, 2% (younger pediatric cohort) (Drug)
Naftin® Cream, 2% (older pediatric cohort)
Experimental
Subject aged 6 years to 11 years, 11 months with tinea corporis
干预措施: Naftin® Cream, 2% (older pediatric cohort) (Drug)
结局指标
主要结局
To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis
时间窗: 2 weeks
AUC0-24, Cmax, AUC0-24/D, Cmax/D, AUCt,ss, Cmax,ss, AUCt,,ss/D, Cmax,ss/D
次要结局
- Evaluate urine PK single and multiple dose variables(2 weeks)
- Evaluate plasma PK single and multiple dose PK variables(2 weeks)
- Evaluate trough plasma PK concentration(2 weeks)
研究者
研究点 (3)
Loading locations...
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