NCT04358770已完成1 期
Single Exposure Bioequivalence Study to Evaluate the Vasoconstriction Activity of Topically Applied Cloderm® (Clocortolone Pivalate) 0.1% Cream and Clocortolone Pivalate 0.1% Cream (Taro Pharmaceuticals) in Healthy Male and Female Volunteers With Normal Skin Under Occlusive Conditions.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- AUEC0-24 (area under the effect curve)
研究概览
简要总结
To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal or clinically insignificant dermatological history the Screening visit and Day 1dosing;
排除标准
- •Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;
- •History of hypersensitivity to the study products or any topical or systemic corticosteroids;
研究组 & 干预措施
Test
Experimental
Clocortolone Pivalate Cream, 0.1%
干预措施: Clocortolone Pivalate (Drug)
Reference
Active Comparator
Cloderm® (clocortolone pivalate) Cream, 0.1%
干预措施: Clocortolone Pivalate (Drug)
结局指标
主要结局
AUEC0-24 (area under the effect curve)
时间窗: 24 hours
value for the blanching intensity vs. time profile
次要结局
未报告次要终点
研究者
研究点 (1)
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