NCT00841594已完成1 期
MXQ-503 Applied To The Hand 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 12 人开始时间: 2009年2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
- 12
- 试验地点
- 1
- 主要终点
- Measurement and comparison of the levels of nitroglycerin and its dinitrate 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 this clinical study is to compare the pharmacokinetic profiles of a topical cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 50 years of age
- •Subjects who do not take any prescription medication or who can safely discontinue use prior to visit
- •Negative pregnancy test for fertile women and agree to use effective contaception throughout the study.
排除标准
- •Subjects who can not safely discontinue current prescription medications.
- •Subjects who have a known allergy to nitroglycerin or common topical formulation ingredients.
- •Subjects with an unstable medical problem.
- •Subjects who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
- •Subjects who participated in a study of any investigational drug or device within four weeks prior to Visit
- •Subjects who have screening laboratory values which are outside the normal range and which are considered to be clinically significant to the investigator.
- •Subjects who have had major abdominal, thoracic, or vascular surgery within six months of Visit
- •Subjects with non-epithelialized skin lesions or interfering skin conditions at time of screening in the area where either study medication is to be applied.
- •Pregnant or nursing women.
- •Women of childbearing potential who are unable or unwilling to comply with the contraceptive requirements during the study period.
研究组 & 干预措施
1
Active Comparator
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
Applied to the hand.
干预措施: nitroglycerin 0.9 % (MXQ-503) (Drug)
2
Active Comparator
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
Applied to the chest.
干预措施: Nitroglycerin ointment 2%, USP (Drug)
结局指标
主要结局
Measurement and comparison of the levels of nitroglycerin and its dinitrate 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: 12 hours
次要结局
- Observation for any adverse events such as headache.(3 weeks)
研究者
研究点 (1)
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