Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen
- Conditions
- Pharmacokinetics
- Interventions
- Registration Number
- NCT02974361
- Lead Sponsor
- Oxford Pharmascience Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Healthy male or female subjects
- BMI 18 - 30 kg/m2
- Willing and able to provide written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part C Ibuprofen LDH Excipient Combo 1 Ibuprofen-LDH - Part C Ibuprofen LDH Excipient Combo 2 Ibuprofen-LDH - Part B Ibuprofen LDH Excipient Combo 2 Ibuprofen-LDH - Part A Ibuprofen-LDH Ibuprofen-LDH - Part A Ibuprofen-LDH Excipient Combo 1 Ibuprofen-LDH - Part A Ibuprofen-LDH Excipient Combo 2 Ibuprofen-LDH - Part C Ibuprofen LDH Excipient Combo 3 Ibuprofen-LDH - Part A Ibuprofen-LDH Excipient Combo 3 Ibuprofen-LDH - Part A Ibuprofen-LDH Excipient Combo 4 Ibuprofen-LDH - Part B Ibuprofen LDH Excipient Combo 1 Ibuprofen-LDH - Part B Ibuprofen LDH Excipient Combo 3 Ibuprofen-LDH - Part B Ibuprofen LDH Excipient Combo 4 Ibuprofen-LDH - Part B Ibuprofen LDH Excipient Combo 5 Ibuprofen-LDH - Part B Ibuprofen Ibuprofen - Part A Ibuprofen control Ibuprofen - Part A Ibuprofen Lysine Ibuprofen Lysine - Part C Ibuprofen Ibuprofen -
- Primary Outcome Measures
Name Time Method Cmax 12 hours AUC(0-inf) 12 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Simbec Orion Ltd
🇬🇧Merthyr Tydfil, United Kingdom