CLINICAL TRIALS PROFILE FOR IBUPROFEN LYSINE
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All Clinical Trials for ibuprofen lysine
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00440804 ↗ | Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA | Completed | Farmacon | Phase 3 | 2002-12-01 | The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine iv in premature infants in the early treatment of Patent Ductus Arteriosus. |
| NCT02452450 ↗ | Ibuprofen and Paracetamol Pharmacokinetic Study | Completed | Simbec Research | Phase 1 | 2014-01-01 | The purpose of this study was to determine rates of absorption of Ibuprofen and Paracetamol formulations. |
| NCT02452450 ↗ | Ibuprofen and Paracetamol Pharmacokinetic Study | Completed | Reckitt Benckiser Healthcare (UK) Limited | Phase 1 | 2014-01-01 | The purpose of this study was to determine rates of absorption of Ibuprofen and Paracetamol formulations. |
| NCT02974361 ↗ | Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen | Completed | Oxford Pharmascience Ltd | Phase 1 | 2016-12-01 | 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. |
| NCT03180879 ↗ | Ibuprofen Bioavailability Study | Completed | Simbec Research | Phase 1 | 2017-04-10 | This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be taken without water and can be used 'on the go'. Vanquish has an improved organoleptic profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as a suitable dosage form for children who may be reluctant to swallow tablets. This product has the potential for application in both adults and children due to the convenience of the format and the ease of administration for both groups. This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation. |
| NCT03180879 ↗ | Ibuprofen Bioavailability Study | Completed | Reckitt Benckiser Healthcare (UK) Limited | Phase 1 | 2017-04-10 | This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be taken without water and can be used 'on the go'. Vanquish has an improved organoleptic profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as a suitable dosage form for children who may be reluctant to swallow tablets. This product has the potential for application in both adults and children due to the convenience of the format and the ease of administration for both groups. This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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