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This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH. Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new version of ibuprofen is expected to produce fewer stomach/intestine related side effects when compared to many existing marketed formulations of Ibuprofen.
This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way crossover and Part C is a maximum of a 4 way crossover. The size of Parts B & Part C and allocated interventions will be confirmed after review of data from Parts A and/or B respectively.
A total of 30 subjects will take part in the study; 10 per study part.
The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and without a selection of different excipients. The pharmacokinetic properties will include how quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug that reaches the bloodstream.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Ibuprofen control | Active Comparator |
| |
| Part A Ibuprofen-LDH | Experimental |
| |
| Part A Ibuprofen-LDH Excipient Combo 1 | Experimental |
| |
| Part A Ibuprofen-LDH Excipient Combo 2 | Experimental |
| |
| Part A Ibuprofen-LDH Excipient Combo 3 | Experimental |
| |
| Part A Ibuprofen-LDH Excipient Combo 4 | Experimental |
| |
| Part A Ibuprofen Lysine | Active Comparator |
| |
| Part B Ibuprofen |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug |
| ||
| Ibuprofen Lysine |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 12 hours | |
| AUC(0-inf) | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annelize Koch | Simbec Orion Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simbec Orion Ltd | Merthyr Tydfil | CF48 4DR | United Kingdom |
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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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| Active Comparator |
|
| Part B Ibuprofen LDH Excipient Combo 1 | Experimental |
|
| Part B Ibuprofen LDH Excipient Combo 2 | Experimental |
|
| Part B Ibuprofen LDH Excipient Combo 3 | Experimental |
|
| Part B Ibuprofen LDH Excipient Combo 4 | Experimental |
|
| Part C Ibuprofen | Active Comparator |
|
| Part C Ibuprofen LDH Excipient Combo 1 | Experimental |
|
| Part C Ibuprofen LDH Excipient Combo 2 | Experimental |
|
| Part C Ibuprofen LDH Excipient Combo 3 | Experimental |
|
| Part B Ibuprofen LDH Excipient Combo 5 | Experimental |
|
| Drug |
|
| Ibuprofen-LDH | Drug |
|