NCT00924079Unknown不适用
Pharmacokinetic Study of Oral Nalbuphine in Normal Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter eq Cmax, AUC, Cl, T1/2
研究概览
简要总结
The purpose of this study is to investigate possible responses to pharmacokinetic properties for nalbuphine oral formulations in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal healthy adult subjects between 20-40 years of age.
- •Body weight within 80-120% of ideal body weight. Ideal body weight = (height-80)0.7
- •Acceptable medical history and physical examination including:
- •Normal chest X-ray and ECG results within six months prior to Period I dosing.
- •No particular clinical significance in general disease history within two months prior to Period I dosing.
- •Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to Period I dosing, which includes:
- •AST (SGOT)
- •ALT (SGPT)
- •alkaline phosphatase
- •total bilirubin
- •uric acid
- •creatinine
- •total cholesterol
- •triglyceride(TG)
- •Acceptable hematology within two months prior to the study, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets.
- •Acceptable urinalysis within two months prior to the study, which includes pH, blood, glucose and protein.
- •Signed the written informed consent to participate in this study.
排除标准
- •Recent history of drug or alcohol addiction or abuse.
- •A clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
- •History of allergic response(s) to nalbuphine or related drugs.
- •History of clinically significant allergies including drug allergies or allergic bronchial asthma.
- •Evidence of chronic or acute infectious diseases.
- •Any clinically significant illness or surgery during the four weeks prior to Period I dosing (as determined by the clinical investigator).
- •Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
- •Receiving any investigational drug within one month prior to Period I dosing.
- •Taking any prescription medication or any nonprescription medication within two weeks prior to Period I doing.
- •Donating greater than 150 ml of blood within two months prior to Period I dosing or donating plasma (e.g., plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
- •Consumption of caffeine, xanthine-containing products (i.e., coffee, tea, caffeine-containing sodas, colas and chocolate, etc.) and/or alcohol at least 48 hours prior to days on which dosing is scheduled and during the periods when blood samples are being collected.
- •Any other medical reason as determined by the clinical investigator.
- •Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline.
研究组 & 干预措施
nalbuphine
Experimental
干预措施: nalbuphine (Drug)
结局指标
主要结局
Pharmacokinetic parameter eq Cmax, AUC, Cl, T1/2
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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