NCT07033845招募中1 期
Pharmacokinetic Study of Topical Phenylephrine
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile of phenylephrine
研究概览
简要总结
Pharmacokinetic Study of Topical Phenylephrine
详细描述
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of Topical Phenylephrine Applied to the Scalp in Healthy Adult Females
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females, age 18-55
- •BMI: 18-30 kg/m²
- •Fitzpatrick Skin Types I-IV (to standardize absorption risk)
- •Scalp free from irritation, dermatologic disease, or damage
- •Able to refrain from using other topical scalp products
排除标准
- •History of cardiovascular disease, hypertension, or arrhythmia
- •Scalp infections, wounds, or significant hair loss
- •Recent use of medications that interfere with CYP enzymes or adrenergic systems
- •Known sensitivity to phenylephrine or ethanol
- •Positive drug screen or abnormal ECG at screening
结局指标
主要结局
Pharmacokinetic profile of phenylephrine
时间窗: Week [0,3]
Determine the amount of phenylephrine and its metabolites in serum daily scalp application of topical phenylephrine for a period of 3 weeks
次要结局
- Safety and tolerability of phenylephrine(Week [0, 3])
研究者
研究点 (1)
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