NCT00513994已完成1 期
MQX-503 Applied to the Fingers vs. Nitroglycerin Ointment 2%, USP, Applied to the Chest: A Pharmacokinetic Comparison in Normal Subjects
MediQuest Therapeutics1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2007年8月最近更新:
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
- 6
- 试验地点
- 1
- 主要终点
- The primary objective is the measurement and comparison of the levels of nitroglycerin and its metabolites in the blood of healthy human volunteers after a single topical dose of MQX-503 and a single topical dose of Nitroglycerin Ointment 2%, USP.
研究概览
简要总结
The purpose of the study is to measure how much nitroglycerin or its metabolites may be found in the bloodstream when MQX-503 or an FDA approved Nitroglycerin ointment 2% USP is applied to the skin of healthy subjects.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers 18 - 70 years of age.
- •Subjects able to give written informed consent and comply with study requirements.
- •Subjects willing and able to safely discontinue all current prescription therapies.
- •Subjects who will agree not to participate in other clinical trials.
- •Negative pregnancy test in fertile females and agreement to use effective contraception throughout the study.
排除标准
- •Persons who would be put at risk by discontinuing prescription therapies.
- •Subjects with a known allergy to nitroglycerin.
- •Subjects who have a condition or issue that would adversely affect the application of study medication, study evaluations or the subject's ability to comply with the protocol.
- •Subjects who recently experienced myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension.
- •Subjects who have participated in a study of an investigational drug within two weeks of visit
- •Subjects who have screening lab values that are out of range or are considered clinically significant by the investigator.
- •Subjects who have had major abdominal, thoracic, or vascular surgery within 6 months of visit
- •Subjects with non-epithelialized skin lesions or interfering skin conditions at the time of screening in the area where study medication is to be applied.
- •Pregnant or nursing women.
- •Women of childbearing potential who are unwilling to comply with the contraceptive requirements.
研究组 & 干预措施
1
Active Comparator
干预措施: Nitroglycerin (Drug)
结局指标
主要结局
The primary objective is the measurement and comparison of the levels of nitroglycerin and its metabolites in the blood of healthy human volunteers after a single topical dose of MQX-503 and a single topical dose of Nitroglycerin Ointment 2%, USP.
时间窗: 8 hours
次要结局
- A secondary objective is the observation of the volunteers for any adverse events(2 weeks)
研究者
研究点 (1)
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