NCT01986660已完成1 期
Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults
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
- 14
- 试验地点
- 1
- 主要终点
- Cmax, Tmax, Trough Concentrations Days 2 to 8, AUC 0-24, Steady State, T1/2
研究概览
简要总结
The purpose of this study is to evaluate how Ibuprofen Cream (SST-0225) is absorbed and eliminated by the body under defined maximum dosing conditions and to evaluate the safety under these conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed consent form
- •Men, women, 18 to 55 years
- •Females must not be pregnant or plan to become pregnant
- •BMI 18 to 30 kg/m2
- •Past or non-smoker
- •High probability of compliance with completion of study
- •Healthy as determined by investigator based on medical history, physical exam, clinical laboratory tests, vital sign measurements, ECGs
排除标准
- •Presence or history of disorder that could interfere with completion of study
- •Unstable medical condition
- •Surgical or medical condition that may interfere with absorption, distribution, metabolism or excretion of test drug
- •Positive Hep B, Hep C and/or HIV test
- •Positive urine drug screen
- •Any history of skin disorders, including psoriasis, eczema, tattoos, significant scarring, healing wounds, skin lesions on knees or elbows
- •Significant disease
- •Any clinically important deviation from normal limits in physical exam, vital sign measurements, 12 lead ECG, clinical laboratory test
- •History of drug abuse with 1 year
- •History of alcoholism with 1 year
- •Use of prescription medications or ibuprofen within 30 days of Day 1, use of OTC drugs, herbal supplements and vitamins within 14 days of Day
- •Use of investigational drug within 30 day of Day 1
- •Acute disease state within 7 days of Day 1
- •Consumption of grapefruit or grapefruit containing products within 72 hours of Day 1
- •Tobacco use/caffeine use within 48 hours of Day 1
研究组 & 干预措施
Ibuprofen Cream (SST-0225)
Experimental
干预措施: Ibuprofen Cream (SST-0225) (Drug)
结局指标
主要结局
Cmax, Tmax, Trough Concentrations Days 2 to 8, AUC 0-24, Steady State, T1/2
时间窗: 9 days
次要结局
- Clinical laboratory change from baseline(14 days)
- Vital Signs(14 days)
- Modified Berger Bowman Skin Assessment(14 days)
- Adverse Events(14 days)
研究者
研究点 (1)
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