Comparative Effects of Rapid-Release Aspirin and NHP-544C on Basal and Bradykinin Stimulated Prostacyclin Production
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Urine Thromboxane Concentrations at Placebo ASA or Placebo NHP-544C Dose
研究概览
简要总结
The investigators will compare the effects of rapid release aspirin and NHP-544C on the prostacyclin response to intravenous bradykinin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Ages of 18 and 55 years, inclusive
- •No significant medical issues without significant abnormal findings at the baseline physical examination
- •Body mass index (BMI) between 18.0 and 30.0kg/m2 (weight (kg)/[height(m)]2)
- •For women - negative pregnancy test on Period 1, Day -1, or surgically sterilized, or is at least two years post-menopausal prior to randomization. Females of childbearing potential must be practicing an acceptable method of birth control to be eligible. Acceptable forms of birth control include: condom plus spermicide or condom plus other form of birth control including hormonal method (IUD, patch, ring, implant, or injectable), sterilization of partner, or non-hormonal IUD. The use of oral contraceptives is allowed during the study, but the subject must be on a stable dose for 30 days prior to the trial and throughout all four dosing periods
- •Ability to understand the requirements of the study and a willingness to comply with all study procedures
排除标准
- •Clinically significant and relevant medical history (including failure of a major organ system) or current medical illness, and is deemed by the Principal Investigator to be unsuitable to participate in the study
- •Participation in an investigational drug study within the 30 days prior to CRC admission
- •Use of aspirin or other NSAID within 14 days of Day 1 of the study. All other medications, prescription (with the exception of contraceptives), over-the-counter (OTC), herbal, and vitamin supplements must be discontinued 7 days prior to Day
- •If subjects are taking prescription medication, or OTC medication at the direction of a health care provider, that provider must confirm that it is acceptable for them to stop dosing for the duration of the study
- •History of metabolic, renal, hepatic, hemorrhagic stroke, gastrointestinal bleed, cardiovascular disease, central nervous system disorder, or peptic ulcer disease or other chronic bleeding disorder
- •History of gastrointestinal disorder that could result in incomplete absorption of the study drug
- •Malignancy, or neurologic or psychiatric disorder
- •Abnormal laboratory value(s) determined to be clinically significant (in the opinion of the Investigator)
- •History of illicit drug abuse in the past year or current evidence of such abuse in the opinion of the investigator
- •Pregnancy or lactation
- •Acute illness within 1 week of CRC admission
- •Significant loss of blood or blood or plasma donation within 30 days of drug administration
- •Hypersensitivity or allergy to NSAIDs, aspirin, ethylcellulose, polyvidone, castor oil, magnesium stearate, tartaric acid, colloidal anhydrous silica, talc, gelatin, titanium dioxide, erythrosine, or indigotin
- •History of aspirin resistance
- •History of alcohol abuse within past year. Current alcohol use should not exceed 14 standard alcoholic drinks per week. A drink is defined as 1.5 ounces (oz.) liquor, 12 oz. beer, or 6 oz. wine
- •Alcohol consumption within 3 days of Day 1
- •Difficulty swallowing oral medications
- •Consumption of coffee or caffeine-containing beverages exceeding the equivalent of five 8-oz cups of coffee per day on average
研究组 & 干预措施
Group 1:Aspirin/placebo
Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
干预措施: Bradykinin (Drug)
Group 1:Aspirin/placebo
Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
干预措施: Aspirin 81 mg (Drug)
Group 1:Aspirin/placebo
Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
干预措施: Aspirin 162 mg (Drug)
Group 1:Aspirin/placebo
Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
干预措施: Placebo (Drug)
Group 2:NHP-544C/placebo
Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
干预措施: Bradykinin (Drug)
Group 2:NHP-544C/placebo
Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
干预措施: NHP544-C 81 mg (Drug)
Group 2:NHP-544C/placebo
Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
干预措施: NHP544C 162 mg (Drug)
Group 2:NHP-544C/placebo
Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Urine Thromboxane Concentrations at Placebo ASA or Placebo NHP-544C Dose
时间窗: 24 hour collection
Urine Thromboxane Concentrations at 81mg ASA or NHP-544C Dose
时间窗: 24 hour collection
Urine Thromboxane Concentrations at 162.5 mg ASA or NHP-544C Dose
时间窗: 24 hour collection
Urine Prostacyclin Concentrations at Placebo ASA or Placebo NHP-544C Dose
时间窗: 24 hour collection
Urine Prostacyclin Concentrations at 81 mg ASA or NHP-544C Dose
时间窗: 24 hour collection
Urine Prostacyclin Concentrations at 162.5 mg ASA or NHP-544C Dose
时间窗: 24 hour collection
次要结局
未报告次要终点
研究者
Nancy J. Brown
M.D.; Professor of Medicine and Pharmacology
Vanderbilt University