Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Ibuprofen Lysine
* Drug: Ibuprofen-LDH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Part A Ibuprofen control<br> | Drug: Ibuprofen<br> <br> |
| Experimental: Part A Ibuprofen-LDH<br> | Drug: Ibuprofen-LDH<br> <br> |
| Experimental: Part A Ibuprofen-LDH Excipient Combo 1<br> | Drug: Ibuprofen-LDH<br> <br> |
| Experimental: Part A Ibuprofen-LDH Excipient Combo 2<br> | Drug: Ibuprofen-LDH<br> <br> |
| Experimental: Part A Ibuprofen-LDH Excipient Combo 3<br> | Drug: Ibuprofen-LDH<br> <br> |
| Experimental: Part A Ibuprofen-LDH Excipient Combo 4<br> | Drug: Ibuprofen-LDH<br> <br> |
| Active Comparator: Part A Ibuprofen Lysine<br> | Drug: Ibuprofen Lysine<br> <br> |
| Active Comparator: Part B Ibuprofen<br> | Drug: Ibuprofen<br> <br> |
| Experimental: Part B Ibuprofen LDH Excipient Combo 1<br> | Drug: Ibuprofen-LDH<br> <br> |
| Experimental: Part B Ibuprofen LDH Excipient Combo 2<br> | Drug: Ibuprofen-LDH<br> <br> |
| Experimental: Part B Ibuprofen LDH Excipient Combo 3<br> | Drug: Ibuprofen-LDH<br> <br> |
| Experimental: Part B Ibuprofen LDH Excipient Combo 4<br> | Drug: Ibuprofen-LDH<br> <br> |
| Active Comparator: Part C Ibuprofen<br> | Drug: Ibuprofen<br> <br> |
| Experimental: Part C Ibuprofen LDH Excipient Combo 1<br> | Drug: Ibuprofen-LDH<br> <br> |
| Experimental: Part C Ibuprofen LDH Excipient Combo 2<br> | Drug: Ibuprofen-LDH<br> <br> |
| Experimental: Part C Ibuprofen LDH Excipient Combo 3<br> | Drug: Ibuprofen-LDH<br> <br> |
| Experimental: Part B Ibuprofen LDH Excipient Combo 5<br> | Drug: Ibuprofen-LDH<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | 12 hours | 
| AUC(0-inf) |  | 12 hours |