(Total Views: 413)
Posted On: 01/30/2020 2:51:55 PM
Post# of 72440
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
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
(5)
(1)
Scroll down for more posts ▼