NCT00663481已完成1 期
A Single Dose, Within Subject, 3 Period, Pharmacokinetic Bridging Study of CoFactor Formulations and of Leucovorin Administered Intravenously in Healthy, Adult Subjects.
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
- 15
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of CoFactor in healthy subjects.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females age 18-65 inclusive at screening.
- •Subject has to agree to practice abstinence or medically accepted contraception and not to participate in sperm donation or in vitro fertilization.
- •Body Mass Index in the range of 18 to 30 kg/m2 and body weight of 45 to 95 kg.
- •Subject must be healthy as determined by the investigator on the basis of screening evaluations.
- •Subject must be nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the in-clinic stay.
排除标准
- •Presence of clinically significant illness within 21 days prior to dosing, viral or bacterial infection, or documented drug allergies that may affect subject's safety during the study.
- •Laboratory or clinical evidence suggestive of disease.
- •Clinically significant or predisposing disorder that may interfere with the absorption, distribution, metabolism and/or excretion of drugs.
- •History of drug abuse within 1 year of dosing and/or admitted alcohol abuse or history of alcohol use that may interfere with the ability to comply.
- •Pregnant, lactating, or positive pregnancy test.
- •Clinically significant electrocardiogram abnormalities.
- •History of positive test for hepatitis B or C, or HIV.
- •Positive findings of urine narcotic screen.
- •History of drug allergy.
研究组 & 干预措施
1
Experimental
CoFactor
干预措施: CoFactor (Drug)
2
Experimental
CoFactor
干预措施: CoFactor (Drug)
3
Active Comparator
Leucovorin
干预措施: Leucovorin (Drug)
结局指标
主要结局
Pharmacokinetic profile of CoFactor formulations in healthy adult subjects.
次要结局
- To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration
研究者
研究点 (1)
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