NCT02713802已完成1 期
An Open-Label, Randomized, Two-Way Crossover Pilot Study of the Bioequivalence of Cudafol(R) and Diprivan(R) IV Administered as Single Intravenous Doses in Healthy Subjects
Cuda Anesthetics, LLC0 个研究点目标入组 8 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 主要终点
- Bioequivalence based on pharmacokinetic parameter: Area Under Curve
研究概览
简要总结
Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single doses of Cudafol(R) and Diprivan(R) in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-obese men and women, 18 to 55 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Females of child-bearing potential must be using an approved contraceptive method.
排除标准
- •Evidence or history of clinically significant disease.
- •History or presence of clinically significant abnormal 12-lead electrocardiogram (ECG), blood pressure, or heart rate.
- •Pregnant or nursing (lactating) women.
- •Known hypersensitivity or allergy to propofol (or components of either formulation, including eggs, soybean oil or betadex sulfobutyl ether sodium) or any other forms of anesthesia, or has had a reaction to anesthesia in the past.
- •Family history of malignant hyperthermia.
- •History of drug or alcohol abuse (or tests positive at screening) or current smoker.
- •Poor venous access in either arm.
- •Tests positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody.
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Test product
Experimental
Propofol solution (1% [10 mg/mL]), via intravenous injection
干预措施: Cudafol(R) (propofol, 1% [10 mg/mL]) (Drug)
Reference product
Active Comparator
Propofol emulsion (1% [10 mg/mL]), via intravenous injection
干预措施: Diprivan(R) (propofol, 1% [10 mg/mL]) (Drug)
结局指标
主要结局
Bioequivalence based on pharmacokinetic parameter: Area Under Curve
时间窗: 0-24 hours post dose
Bioequivalence based on pharmacokinetic parameter: Cmax
时间窗: 0-24 hours post dose
次要结局
- Incidence of adverse events and tolerability(7 days post dose)
- Pharmacokinetic parameter: Tmax(0-24 hours post dose)
研究者
相似试验
已完成
1 期
A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects.HealthyNCT04322266Hanmi Pharmaceutical Company Limited61
已完成
1 期
A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy Subjects.HealthyNCT05191563Hanmi Pharmaceutical Company Limited56
已完成
1 期
Study to Compare Two Formulations of Lamotrigine in Healthy SubjectsMental DisordersNCT00410371GlaxoSmithKline96
已完成
1 期
Phase 1 Clinical Trial to Investigate the Effect on the Pharmacokinetics of YH14755 Compared to Co-administration of Rosuvastatin and Metformin SR in Healthy VolunteersHealthyNCT02125227Yuhan Corporation56
已完成
1 期
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy ParticipantsHealthyNCT05378906Janssen Research & Development, LLC32