KCT0001286进行中（未招募）未知
An open label, randomized, single dose, crossover study to evaluate pharmacokinetics of actiq undergoing hyperthermia in healthy adult volunteers
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 55(Year)（—）
- 性别
- All
入选标准
- •1. Healthy adult aged 19-55 years
- •2. BMI of 17.5-30.5 kg/m2 and weight = 45 kg
- •3. No congenital disease, no chronic disease within the past three years, and no abnormal finding in the internal medicine examination
- •4. Passed the screening tests, including laboratory tests such as hematology, blood chemistry, and urinalysis
- •5. Signed the Informed Consent Form
- •6. Can participate in and complete the study
排除标准
- •1. Has a past or current history of a hematological, renal, endocrinological, respiratory, gastrointestinal, urological, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (except for an asymptomatic seasonal allergy that has not been treated at the time of administration of the investigational drug)
- •2. Has a past history of a gastrointestinal disease that may affect the drug absorption (e.g., an esophageal disease such as achalasia or esophageal stenosis, or Crohn’s disease) or surgery (except for appendectomy or inguinal hernia repair)
- •3. Had an alcohol intake of > 210 g/week within six months before the screening [one cup of beer (5%) (250 ml) = 10 g; one cup of soju (20%) (50 ml) = 8 g; and one cup of wine (12%) (125 ml) = 12 g]
- •4. Participated in another clinical study within two months before this study
- •5. Has a systolic blood pressure = 140 mmHg and a diastolic blood pressure = 90 mmHg
- •6. Had alcohol or drug abuse within one year before the screening
- •7. Received drugs known to significantly induce or suppress CYPs within one month before this study
- •8. Smokes 20 cigarettes or more a day
- •9. Received prescription or OTC drugs within 10 days before this study
- •10. Donated blood within two months before this study (including apheresis)
- •11. Has a modest or chronic medical or psychiatric disease and abnormal laboratory test results that may compromise the interpretation of the results of this study
- •12. Pregnant or lactating
- •13. Has intolerance or hypersensitivity to the ingredients of fentanyl
- •14. Cannot tolerate opioids
- •15. Cannot comply with the lifestyle guidelines described in the study protocol
- •16. Considered by the investigator capable of participating in this study
研究者
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