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
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.
Inclusion Criteria:
Exclusion Criteria: