A study looking at the effect on PK of excipients in Ibuprofen-LDH
Research type
Research Study
Full title
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 (OXPzero Advancing Technology (OAT) Study)
IRAS ID
216758
Contact name
Annelize Koch
Contact email
Sponsor organisation
Oxford Pharmascience Ltd
Eudract number
2016-003496-22
Duration of Study in the UK
0 years, 4 months, 22 days
Research 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. A total of 30 subjects will take part in the study.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.
The population who are eligible to take part in the study are healthy male or female (non pregnant/breastfeeding), non-smoking volunteers (or ex smokers of at least 12 months), aged between 18 and 55 years, as determined by screening tests at Simbec.
Participation in the trial will be dependent on which part the subject is enrolled onto. It will take between 6-8 weeks (from first screening visit to final end of study visit).
REC name
Wales REC 2
REC reference
16/WA/0338
Date of REC Opinion
18 Nov 2016
REC opinion
Favourable Opinion