Ignite Creation Date:
2024-05-06 @ 9:25 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02974361
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2016-11-21
Brief Title:
Impact of Excipients on Pharmacokinetics of OXPzeroTM Ibuprofen
Sponsor:
Oxford Pharmascience Ltd
Organization:
Oxford Pharmascience Ltd
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 stomachintestine 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 andor 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
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 andor 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None