Trial Condition(s):
Moderate Pain
A study to assess disintegration of the new Aspirin disintegrating tablets
Bayer Identifier:
19220
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study Completed
Trial Purpose
The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Summary
Enrollment Goal
12
Trial Dates
Phase
1
Could I receive a placebo?
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteers
Yes
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations Bio-Images Research Ltd Glasgow, United Kingdom, G4 0SF | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
N/A
Assignment:
Crossover Assignment
Trial Arms:
4
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 identifiedTimeframe: Up to 4 hours
Secondary Outcome
- Gastric empty time, if applicableGastric emptying time will be calculated by a qualified assessor based on the scintigraphy imagesTimeframe: Up to 4 hours
- Time of colon arrival, if applicableTime of colon arrival will be calculated by a qualified assessor based on the scintigraphy imagesTimeframe: Up to 4 hours
- Small intestine transit time, if applicableSmall intestine transit time will be calculated by a qualified assessor based on the scintigraphy imagesTimeframe: 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 imagesTimeframe: 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 imagesTimeframe: 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 imagesTimeframe: 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 imagesTimeframe: 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 imagesTimeframe: 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 imagesTimeframe: Up to 4 hours
- AUC0-tArea under the plasma concentration vs time curve from zero to the last data pointTimeframe: 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 administrationTimeframe: 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 infinityTimeframe: 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 slopeTimeframe: 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 measuredTimeframe: 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-infinityTimeframe: 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
Additional Information
Not Available
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