A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets
- Conditions
- Moderate Pain
- Interventions
- Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465)Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)Drug: 400 mg ibuprofen(Nurofen)
- Registration Number
- NCT03225352
- Lead Sponsor
- Bayer
- Brief Summary
The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 3: starting with Nurofen 1000 mg acetylsalicylic acid (Aspirin, BAYE4465) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 1: starting with BAYE4465 500 mg 500 mg acetylsalicylic acid (Aspirin, BAYE4465) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 2: starting with BAYE4465 1000 mg 400 mg ibuprofen(Nurofen) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 3: starting with Nurofen 400 mg ibuprofen(Nurofen) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 1: starting with BAYE4465 500 mg 400 mg ibuprofen(Nurofen) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 2: starting with BAYE4465 1000 mg 1000 mg acetylsalicylic acid (Aspirin, BAYE4465) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 4: starting with Dolormin Extra 400 mg ibuprofen(Nurofen) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 1: starting with BAYE4465 500 mg 1000 mg acetylsalicylic acid (Aspirin, BAYE4465) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 2: starting with BAYE4465 1000 mg 400 mg ibuprofen (Dolormin Extra) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 1: starting with BAYE4465 500 mg 400 mg ibuprofen (Dolormin Extra) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 4: starting with Dolormin Extra 500 mg acetylsalicylic acid (Aspirin, BAYE4465) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 4: starting with Dolormin Extra 1000 mg acetylsalicylic acid (Aspirin, BAYE4465) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 4: starting with Dolormin Extra 400 mg ibuprofen (Dolormin Extra) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 2: starting with BAYE4465 1000 mg 500 mg acetylsalicylic acid (Aspirin, BAYE4465) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 3: starting with Nurofen 500 mg acetylsalicylic acid (Aspirin, BAYE4465) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Sequence 3: starting with Nurofen 400 mg ibuprofen (Dolormin Extra) Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
- Primary Outcome Measures
Name Time Method Time to complete tablet disintegration 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
- Secondary Outcome Measures
Name Time Method Time of onset of release of radiolabel Up to 4 hours Time of onset of release of radiolabel will be calculated by a qualified assessor based on the scintigraphy images
Gastric empty time, if applicable Up to 4 hours Gastric emptying time will be calculated by a qualified assessor based on the scintigraphy images
Time of colon arrival, if applicable Up to 4 hours Time of colon arrival will be calculated by a qualified assessor based on the scintigraphy images
Small intestine transit time, if applicable Up to 4 hours Small intestine transit time will be calculated by a qualified assessor based on the scintigraphy images
Site of onset of release of radiolabel Up to 4 hours Site of onset of release of radiolabel will be determined by a qualified assessor based on the scintigraphy images
Site of completion of release of radiolabel Up to 4 hours Site of completion of release of radiolabel will be determined by a qualified assessor based on the scintigraphy images
Disintegration rate of the tablet estimated from the radioactivity remaining Up to 4 hours Disintegration rate of the tablet estimated from the radioactivity rem will be calculated by a qualified assessor based on the scintigraphy images
Time of 50% disintegration of the tablet estimated from the radioactivity remaining Up to 4 hours Time of 50% disintegration of the tablet estimated from the radioactivity remaining will be calculated by a qualified assessor based on the scintigraphy images
Gastric emptying kinetics of dispersed radioactive material (t50% and t90%) Up to 4 hours Gastric emptying kinetics of dispersed radioactive material (t50% and t90%) will be calculated by a qualified assessor based on the scintigraphy images
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 Area under the plasma concentration vs time curve from zero to the last data point
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 Maximum drug concentration in plasma after single dose administration
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 Area under the plasma concentration vs time curve from zero to infinity
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 Half-life associated with the terminal slope
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 Time to reach maximum drug concentration in the measured
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
Trial Locations
- Locations (1)
Bio-Images Research Ltd
🇬🇧Glasgow, Glasgow City, United Kingdom