Pharmacokinetics
Conditions
Brief 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.
Interventions
Sponsors
Oxford Pharmascience Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female subjects * BMI 18 - 30 kg/m2 * Willing and able to provide written informed consent
Exclusion criteria
* Evidence or history of significant renal, hepatic, gastrointestinal, central nervous system, respiratory, cardiovascular, autoimmune or metabolic dysfunction * Recent or concurrent use of prescription or non-prescription medications, other than contraceptives * Allergy or sensitivity to NSAIDs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax | 12 hours |
| AUC(0-inf) | 12 hours |
Countries
United Kingdom
Outcome results
None listed