Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen

• Status: Completed
• Trial end date: 2017-05-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oxford Pharmascience Ltd
• Treatments: Ibuprofen

Criteria

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