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| Name | Class |
|---|---|
| Simbec Research | INDUSTRY |
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The purpose of this study was to determine rates of absorption of Ibuprofen and Paracetamol formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen lysine | Experimental |
| |
| Ibuprofen sodium | Experimental |
| |
| Ibuprofen liquid capsules | Experimental |
| |
| Ibuprofen acid | Active Comparator |
| |
| Paracetamol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen Acid | Drug |
| ||
| Ibuprofen Lysine |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the maximum concentration (Cmax) of the reference Ibuprofen | 0-4hr | |
| Time to the first extrapolated non-zero concentration (Tlag) | 0-4hr | |
| Time to the maximum concentration (Tmax) | 0-4hr |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the lower therapeutic level reaching at least 5 µg/ml (T5.0) for ibuprofen and paracetamol | 0-4hr | |
| Time to the mid therapeutic level reaching at least 8.4 µg/ml (T8.4) for ibuprofen and 10 µg/ml (T10.0) for paracetamol | 0-4hr |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29667449 | Derived | Miles L, Hall J, Jenner B, Addis R, Hutchings S. Predicting rapid analgesic onset of ibuprofen salts compared with ibuprofen acid: Tlag, Tlow, Tmed, and a novel parameter, TCmaxRef. Curr Med Res Opin. 2018 Aug;34(8):1483-1490. doi: 10.1080/03007995.2018.1466697. Epub 2018 Apr 27. |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Ibuprofen Sodium | Drug |
|
| Ibuprofen Liquid Capsules | Drug |
|
| Paracetamol | Drug |
|
| Time to the higher therapeutic level reaching at least 10.0 µg/ml (T10.0) for ibuprofen and 20 µg/ml (T20.0) for paracetamol | 0-4hr |
| Partial area under the curve (AUCs) at each nominal blood sampling time-point | 0-4hr |
| The area under the curve up to the median Tmax for the ibuprofen reference product (AUCTmaxRef) | 0-4hr |
| The plasma concentration at each planned nominal time-point (Cn) | 0-4hr |
| The maximum plasma concentration (Cmax) | 0-4hr |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |