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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000732-96 | EudraCT Number |
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The purpose of this study is to evaluate the systemic exposure to ibuprofen after single oromucosal administration of the test product V0498 and single oral administration of a reference product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Other | Test Drug (V0498 - A mg) - Reference (Ibuprofen) |
|
| Sequence 2 | Other | Reference (Ibuprofen) - Test drug(V0498 - A mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V0498 - A mg | Drug | Single oromucosal administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | 11 time points up to 10h after administration | |
| Time of Maximum Concentration | 11 time points up to 10h after administration | |
| Area Under Curve (AUC0-72) | 11 time points up to 10h after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liège | B-4000 | Belgium |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Ibuprofen |
| Drug |
Single oral administration |
|