NCT03826316已完成4 期
A Study to Evaluate Pharmacokinetics of Nalbuphine Hydrochloride (10 mg/mL) After a Single Intravenous Administration in Healthy Volunteers Under Fasting Conditions
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Peak Drug Concentration (Cmax)
研究概览
简要总结
A study to evaluate pharmacokinetics of nalbuphine hydrochloride (10 mg/mL) after a single intravenous administration in healthy volunteers under fasting conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male subjects between 20-45 years of age.
- •Body weight within 80-120% of ideal body weight.
- •* Ideal body weight (kg) = [height (cm) - 80] *0.7 for male subjects
- •Acceptable medical history and physical examination including:
- •no particular clinically significant abnormalities in chest x-ray and electrocardiogram results within six months prior to study drug dosing.
- •no particular clinical significance in general disease history within two months prior to study drug dosing.
- •Acceptable biochemistry determinations (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes Serum Glutamic Oxaloacetic Transaminase (SGOT, same as AST), Serum Glutamic Pyruvic Transaminase (SGPT, same as ALT), Gamma-Glutamyl-Transpeptidase (γ-GT), alkaline phosphatase, total bilirubin, albumin, glucose, Blood Urea Nitrogen(BUN), uric acid, creatinine, total cholesterol and triglyceride (TG).
- •Acceptable hematology (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials and platelets.
- •Acceptable urinalysis (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes power of hydrogen (pH), blood, glucose, ketones, bilirubin and protein.
- •Male subjects willing to use a condom during any sexual contact with females of reproductive potential for up to 10 weeks after study drug dosing.
- •Have signed the written informed consent to participate in the study.
排除标准
- •A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the investigator).
- •A clinically significant illness or surgery within four weeks prior to dosing (as determined by the investigator).
- •History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years.
- •History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
- •Known or suspected history of drug abuse within lifetime as judged by the investigator.
- •History of alcohol addiction or abuse within last five years as judged by the investigator.
- •History of allergic response(s) to nalbuphine hydrochloride or any other related drugs.
- •Evidence of chronic or acute infectious disease.
- •Positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
- •Female subjects demonstrating a positive pregnancy screen prior to the study.
- •Female subjects who are currently breastfeeding.
- •Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks prior to dosing. Examples of inducers include: piperidines, carbamazepine, dexamethasone and rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatin, methadone and ranitidine.
- •Taking any prescription medications within four weeks or any nonprescription medications (excluding flu vaccination) within two weeks prior to dosing.
- •Use of any investigational drug within four weeks prior to dosing.
- •Donating more than 250 milliliter (mL) of blood within two months prior to dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to dosing.
- •Any other medical reason as determined by the investigator.
研究组 & 干预措施
Mutonpain Injection 10 mg/ml
Experimental
干预措施: Nalbuphine (Drug)
结局指标
主要结局
Peak Drug Concentration (Cmax)
时间窗: Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
Area under the (first) moment plasma concentration-time curve (AUMC)
时间窗: Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
Area under the plasma concentration (AUC)
时间窗: Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
Elimiation half-life (T1/2)
时间窗: Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
次要结局
- Adverse events(Adverse event reporting will up to 10 weeks.)
研究者
研究点 (1)
Loading locations...
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