check_circleStudy Completed
Moderate Pain
Bayer Identifier:
19220
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A study to assess disintegration of the new Aspirin disintegrating tablets
Trial purpose
The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets
Key Participants Requirements
Sex
MaleAge
18 - 65 YearsTrial summary
Enrollment Goal
12Trial Dates
August 2017 - October 2017Phase
Phase 1Could I Receive a placebo
NoProducts
Aspirin (Acetylsalicylic Acid, BAYE4465)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Bio-Images Research Ltd | Glasgow, G4 0SF, United Kingdom |
Primary Outcome
- Time to complete tablet disintegrationThe 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 identifieddate_rangeTime Frame:Up to 4 hours
Secondary Outcome
- Gastric empty time, if applicableGastric emptying time will be calculated by a qualified assessor based on the scintigraphy imagesdate_rangeTime Frame:Up to 4 hours
- Time of colon arrival, if applicableTime of colon arrival will be calculated by a qualified assessor based on the scintigraphy imagesdate_rangeTime Frame:Up to 4 hours
- Small intestine transit time, if applicableSmall intestine transit time will be calculated by a qualified assessor based on the scintigraphy imagesdate_rangeTime Frame:Up to 4 hours
- Time of onset of release of radiolabelTime of onset of release of radiolabel will be calculated by a qualified assessor based on the scintigraphy imagesdate_rangeTime Frame:Up to 4 hours
- Site of onset of release of radiolabelSite of onset of release of radiolabel will be determined by a qualified assessor based on the scintigraphy imagesdate_rangeTime Frame:Up to 4 hours
- Site of completion of release of radiolabelSite of completion of release of radiolabel will be determined by a qualified assessor based on the scintigraphy imagesdate_rangeTime Frame:Up to 4 hours
- Disintegration rate of the tablet estimated from the radioactivity remainingDisintegration rate of the tablet estimated from the radioactivity rem will be calculated by a qualified assessor based on the scintigraphy imagesdate_rangeTime Frame:Up to 4 hours
- Time of 50% disintegration of the tablet estimated from the radioactivity remainingTime of 50% disintegration of the tablet estimated from the radioactivity remaining will be calculated by a qualified assessor based on the scintigraphy imagesdate_rangeTime Frame:Up to 4 hours
- Gastric emptying kinetics of dispersed radioactive material (t50% and t90%)Gastric emptying kinetics of dispersed radioactive material (t50% and t90%) will be calculated by a qualified assessor based on the scintigraphy imagesdate_rangeTime Frame:Up to 4 hours
- AUC0-tArea under the plasma concentration vs time curve from zero to the last data pointdate_rangeTime Frame: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
- CmaxMaximum drug concentration in plasma after single dose administrationdate_rangeTime Frame: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-infinityArea under the plasma concentration vs time curve from zero to infinitydate_rangeTime Frame: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
- t1/2Half-life associated with the terminal slopedate_rangeTime Frame: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
- tmaxTime to reach maximum drug concentration in the measureddate_rangeTime Frame: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-infinitydate_rangeTime Frame: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 design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
4