Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen

May 2, 2017 updated by: Oxford Pharmascience Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Merthyr Tydfil, United Kingdom, CF48 4DR
        • Simbec Orion Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford Pharmascience Ltd

Investigators

  • Principal Investigator: Annelize Koch, Simbec Orion Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

April 28, 2017

Study Completion (Actual)

May 3, 2017

Study Registration Dates

First Submitted

November 21, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimate)

November 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OAT-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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