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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004546-29 | EudraCT Number |
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The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: starting with BAYE4465 500 mg | Experimental | Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design |
|
| Sequence 2: starting with BAYE4465 1000 mg | Experimental | Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design |
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| Sequence 3: starting with Nurofen | Experimental | Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design |
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| Sequence 4: starting with Dolormin Extra | Experimental | Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 500 mg acetylsalicylic acid (Aspirin, BAYE4465) | Drug | Single intake of 1 tablet, 500mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete tablet disintegration | 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 | Up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric empty time, if applicable | Gastric emptying time will be calculated by a qualified assessor based on the scintigraphy images | Up to 4 hours |
| Time of colon arrival, if applicable | Time of colon arrival will be calculated by a qualified assessor based on the scintigraphy images |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bio-Images Research Ltd | Glasgow | Glasgow City | G4 0SF | United Kingdom |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| 1000 mg acetylsalicylic acid (Aspirin, BAYE4465) | Drug | Single intake of 1 tablet, 1000mg |
|
| 400 mg ibuprofen(Nurofen) | Drug | Single intake of 1 tablet, 400mg |
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| 400 mg ibuprofen (Dolormin Extra) | Drug | Single intake of 1 tablet, 400mg |
|
| Up to 4 hours |
| Small intestine transit time, if applicable | Small intestine transit time will be calculated by a qualified assessor based on the scintigraphy images | Up to 4 hours |
| Time of onset of release of radiolabel | Time of onset of release of radiolabel will be calculated by a qualified assessor based on the scintigraphy images | Up to 4 hours |
| Site of onset of release of radiolabel | Site of onset of release of radiolabel will be determined by a qualified assessor based on the scintigraphy images | Up to 4 hours |
| Site of completion of release of radiolabel | Site of completion of release of radiolabel will be determined by a qualified assessor based on the scintigraphy images | Up to 4 hours |
| Disintegration rate of the tablet estimated from the radioactivity remaining | Disintegration rate of the tablet estimated from the radioactivity rem will be calculated by a qualified assessor based on the scintigraphy images | Up to 4 hours |
| Time of 50% disintegration of the tablet estimated from the radioactivity remaining | Time of 50% disintegration of the tablet estimated from the radioactivity remaining will be calculated by a qualified assessor based on the scintigraphy images | 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 images | Up to 4 hours |
| AUC0-t | Area under the plasma concentration vs time curve from zero to the last data point | 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 | Maximum drug concentration in plasma after single dose administration | 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-infinity | Area under the plasma concentration vs time curve from zero to 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 |
| t1/2 | Half-life associated with the terminal slope | 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 |
| tmax | Time to reach maximum drug concentration in the measured | 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-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 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |