NCT00614029已完成1 期
A Randomized, Open-Label, Single-Dose, Four-way Crossover Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System Versus IMITREX STATdose at Three Injection Sites in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- The area under the plasma concentration-time curve, maximal plasma concentration, time to maximal concentration, terminal elimination half-life, and apparent terminal elimination rate constant of sumatriptan will be determined at each of 3 sites
研究概览
简要总结
A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system.
详细描述
A single center, randomized, single-dose, open-label, partial-block, four-period, four-way crossover study in 54 healthy adult subjects to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system compared to IMITREX STATdose at three injection sites (abdomen, thigh, and arm.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Healthy subjects
- •Negative serum pregnancy test
- •Female subjects of child-bearing potential must agree to use acceptable birth control 3 weeks prior to and 2 weeks after study dosing.
- •Body Mass Index (BMI) and sufficient subcutaneous thickness, in the opinion of the investigator, for an injection into the abdomen, arm and thigh
- •Non-tobacco user
- •Adequate venous access in the left or right arm to allow collection of a number of blood samples
- •Fluent in the English language
- •Provide written informed consent to participate in the study and be willing to comply with the study procedures
排除标准
- •History within the previous 2 years of drug or alcohol dependence
- •Evidence of clinically relevant oral, cardiovascular, hematologic, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorder
- •History of epilepsy or other neurologic disease
- •History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischemic attack, uncontrolled hypertension, or signs/symptoms of ischemic heart disease
- •History of allergy, anaphylaxis, or hypersensitivity to sumatriptan or similar drugs including sulphonamides
- •History of scleroderma or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications
- •Tattoos or birthmarks in the lateral thigh, abdominal area or arm (deltoid) that are large enough to restrict injection site selection and/or evaluation
- •Positive screening test for HIV antibodies, Hepatitis B surface antigen, or Hepatitis C antibody
- •Positive results on illicit drug test at Screening or at Check-in
- •Use of any prescription medication
结局指标
主要结局
The area under the plasma concentration-time curve, maximal plasma concentration, time to maximal concentration, terminal elimination half-life, and apparent terminal elimination rate constant of sumatriptan will be determined at each of 3 sites
时间窗: one week
次要结局
未报告次要终点
研究者
研究点 (2)
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