NCT00652821已完成1 期
To Compare the Relative Bioavailability of the Kali's Tramadol APAP Tablets With Ortho-McNeil's Ultracet Tablets Under Fed Conditions.
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
- 22
- 主要终点
- Rate and Extent of Absorption
研究概览
简要总结
To compare the relative bioavailability of Kali and Ortho-McNeil's products
详细描述
To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with Ortho-McNeil's Ultracet tablets 37.5mg/325mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Males and females between 18 and 45 years of age inclusive
- •Informed of the nature of the study and given written informed consent.
- •Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100lbs.
排除标准
- •Hypersensitivity to Tramadol/ Acetaminophen, opioids such as morphine and codeine, or related compounds, or a history or seizures.
- •Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
- •Recent history (within one year) of mental illness, drug illness, drug abuse or alcoholism.
- •Donation of greater than 500mL of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
- •Received an investigational drug within the 4 weeks prior to study dosing.
- •Currently taking any prescription medication, except oral contraceptives, within 7days prior to study dosing or over-the-counter medication within 3 days of the study dosing.
- •This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the physician.
- •Tobacco use(>5 cigarettes per day)in the 3 months prior to study dosing.
- •If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods.
- •Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed.
- •Medically acceptable methods of contraception that may be used by the subject and/or her partner are:oral contraceptive, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence.
- •females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
研究组 & 干预措施
A
Experimental
Subjects received Kali product under fed condition
干预措施: Tramadol/ APAP (Drug)
B
Active Comparator
Subjects received Ortho-Mcneil product under fed conditions
干预措施: Ultracet (Drug)
结局指标
主要结局
Rate and Extent of Absorption
时间窗: 24 Hours
次要结局
未报告次要终点
研究者
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