Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen
Summary
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.
Timeline
- Start
- 2016-12
- Primary completion
- 2017-04-28
- Completion
- 2017-05-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ibuprofen | Small molecule | — | — |
| Comparator | Ibuprofen Lysine | Unknown | — | — |
| Subject | Ibuprofen-LDH | Unknown | — | — |
Indications
No indication recorded.