NCT02974361

Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Oxford Pharmascience Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Ibuprofen
DRUG	Ibuprofen Lysine
DRUG	Ibuprofen-LDH

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-04-28
• Completion: 2017-05-03
• First posted: 2016-11-28
• Last updated: 2017-05-03

Locations

1 site across 1 country: United Kingdom