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Full text version: 1. Primary Outcome Measures

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Post# of 72446
(Total Views: 430)
Posted On: 01/30/2020 2:51:55 PM
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Posted By: TreeFrog
Full text version:

1. Primary Outcome Measures :
Site of release of radiolabel [ Time Frame: To 14 hours post-dose ]
Site of release of radiolabel determined by a qualified assessor based on gamma scintigraphy images

2. Time to release of radiolabel [ Time Frame: To 14 hours post-dose ]
Site of release of radiolabel determined by a qualified assessor based on gamma scintigraphy images

3. To visualise radiolabel dispersion within the colon [ Time Frame: To 14 hours post-dose ]
To visualise the disintegration and dispersion of delayed release tablets from gamma scintigraphy images of the colon


Secondary Outcome Measures :
1. Cmax [ Time Frame: To 24 hours post-dose ]
Maximum Plasma Concentration

2. Tmax [ Time Frame: To 24 hours post-dose ]
Time of Maximum Plasma Concentration

3. Tlag [ Time Frame: To 24 hours post-dose ]
Lag Time

4. AUClast [ Time Frame: To 24 hours post-dose ]
Area Under the Curve from time 0 to 24 hours

5. AUC0-inf [ Time Frame: To 24 hours post-dose ]
Area Under the Curve from time 0 to infinity

6. K [ Time Frame: To 24 hours post-dose ]
Terminal First Order Rate constant

7. t1/2 [ Time Frame: To 24 hours post-dose ]
Half Life

8. Adverse Events [ Time Frame: 14 days ]
Number of Participants With Treatment-Emergent Adverse Events



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