An Open-label, Single-dose, Randomised, Crossover Study to Evaluate Changes in the Pharmacokinetics of Ibuprofen From Ibuprofen-LDH Dosed With and Without Release Modifying Excipients in Normal, Healthy, Adult Subjects

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.