NCT03972462已完成1 期
Open-label, Fixed-sequence, Two-period Comparative Bioavailability Study of Sirolimus From Topical Application of NPC-12G Gel to Oral Rapamune® Following Single Administration in Healthy Subjects Under Fasting Conditions
Nobelpharma1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年5月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This study is designed to describe the relative systemic bioavailability of topical and oral sirolimus formulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NPC-12G Gel 0.2% (Period 1)
Experimental
A single 800 mg quantity weight (1.6 mg sirolimus) dose will be applied to the central face on Day 1.
干预措施: NPC-12G Gel 0.2% (Drug)
Rapamune Tablet (Period 2)
Active Comparator
Rapamune® (sirolimus) 2 mg tablet for oral dosing.
干预措施: Rapamune® 2 mg tablet (Drug)
结局指标
主要结局
Cmax
时间窗: Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose
AUC0-48
时间窗: Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose
Tmax
时间窗: Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose
次要结局
未报告次要终点
研究者
研究点 (1)
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