An Open Label, Randomized, Four-Way Crossover Trial to Assess the Disintegration, Gastric Emptying and Pharmacokinetic Parameters of a New Disintegrating Acetylsalicylic Acid 500 mg, 1000 mg Tablet Formulation and 2 Different Ibuprofen Tablets in Fasted Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Time to complete tablet disintegration
研究概览
简要总结
The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged 18 to 65 years included
- •Verified diagnosis of "healthy"
- •Non-smokers or passive smokers
- •BMI in the range of 18.5 to 30 kg/m2
- •Subject has given written informed consent to participate in the trial prior to admission to the trial
排除标准
- •Blood donation within the last 90 days prior to planned randomization
- •Any previous medication within 10 days before the planned administration of the radiolabelled Investigational Medicinal Product (rIMP) which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety
- •Subject has any non-removable metal objects such as metal plates, screws etc. in their chest or abdominal area which, in the opinion of the physician responsible, could affect the study conduct.
- •Vegetarian
- •Subjects for whom participation in this study will exceed the limits of total radiation exposure allowed in any 12 month period (5 Millisievert), or will exceed 10 Millisievert over any three year period
研究组 & 干预措施
Sequence 1: starting with BAYE4465 500 mg
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 500 mg acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
Sequence 1: starting with BAYE4465 500 mg
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
Sequence 1: starting with BAYE4465 500 mg
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 400 mg ibuprofen(Nurofen) (Drug)
Sequence 1: starting with BAYE4465 500 mg
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 400 mg ibuprofen (Dolormin Extra) (Drug)
Sequence 2: starting with BAYE4465 1000 mg
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 500 mg acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
Sequence 2: starting with BAYE4465 1000 mg
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
Sequence 2: starting with BAYE4465 1000 mg
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 400 mg ibuprofen(Nurofen) (Drug)
Sequence 2: starting with BAYE4465 1000 mg
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 400 mg ibuprofen (Dolormin Extra) (Drug)
Sequence 3: starting with Nurofen
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 500 mg acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
Sequence 3: starting with Nurofen
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
Sequence 3: starting with Nurofen
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 400 mg ibuprofen(Nurofen) (Drug)
Sequence 3: starting with Nurofen
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 400 mg ibuprofen (Dolormin Extra) (Drug)
Sequence 4: starting with Dolormin Extra
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 500 mg acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
Sequence 4: starting with Dolormin Extra
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
Sequence 4: starting with Dolormin Extra
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 400 mg ibuprofen(Nurofen) (Drug)
Sequence 4: starting with Dolormin Extra
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
干预措施: 400 mg ibuprofen (Dolormin Extra) (Drug)
结局指标
主要结局
Time to complete tablet disintegration
时间窗: Up to 4 hours
The tablet is radiolabeled. Scintigraphy images of the abdominal area will be taken It is time until an image with no definable hot spot remaining is identified
次要结局
- Time of onset of release of radiolabel(Up to 4 hours)
- Gastric empty time, if applicable(Up to 4 hours)
- Time of colon arrival, if applicable(Up to 4 hours)
- Small intestine transit time, if applicable(Up to 4 hours)
- Site of onset of release of radiolabel(Up to 4 hours)
- Site of completion of release of radiolabel(Up to 4 hours)
- Disintegration rate of the tablet estimated from the radioactivity remaining(Up to 4 hours)
- Time of 50% disintegration of the tablet estimated from the radioactivity remaining(Up to 4 hours)
- Gastric emptying kinetics of dispersed radioactive material (t50% and t90%)(Up to 4 hours)
- AUC0-t(Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose)
- Cmax(Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose)
- AUC0-infinity(Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose)
- t1/2(Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose)
- tmax(Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose)
- Cmax/AUC0-infinity(Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose)