NCT01397214已完成1 期
A Randomized, Open-label, Single-dose, Cross-over Study to Investigate Safety and Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers
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
- 103
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
Phase I study of Megace F will be conducted to investigate pharmacokinetics and safety compared to Megace OS.
Phase I study divided into 3 parts written as belows.
Part 1 Megace F in fasting volunteers vs Megace F in fed volunteers Part 2 Megace F vs Megace OS in fed volunteers Part 3 Megace F vs Megace OS in fasting volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age: 20-55 years body weight: greater than 50kg written informed consent
排除标准
- •known allergy to Megesterol acute or chronic diseases which could affect drug absorption or metabolism positive drug or alcohol screening smokers of 10 or more cigarettes per day 3 month ago participation in a clinical trial during the last 3 months prior to the start of the study
研究组 & 干预措施
Megace F
Experimental
Megace F oral suspension
干预措施: Megace F (Drug)
Megace OS
Active Comparator
Megace acetate oral suspension
干预措施: Megace OS (Drug)
结局指标
主要结局
AUC
时间窗: 0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs
次要结局
- Tmax(0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs)
- t1/2(0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin LymphomaB-cell Non-Hodgkin LymphomaNCT03671018Hoffmann-La Roche422
Unknown
早期 1 期
ET190L1-ARTEMIS™ T Cells in Relapsed, Refractory B Cell Leukemia and LymphomaCD19+ Lymphoma, B-CellCD19+ Leukemia, B-CellNCT03895944First Affiliated Hospital Xi'an Jiaotong University18
进行中（未招募）
1 期
A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin LymphomaB-cell Non Hodgkin LymphomaDiffuse Large B Cell LymphomaHigh-grade B-cell LymphomaFollicular LymphomaNCT04594642AstraZeneca226
Unknown
1 期
An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene FusionNCT04671849Jiangsu Simcere Pharmaceutical Co., Ltd.243
已完成
1 期
A Study of GFH018 in Combination With Toripalimab in Patients With Advanced Solid TumorsAdvanced Solid TumorNCT04914286Genfleet Therapeutics (Shanghai) Inc.148