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Completed

NCT Number: NCT02974361

Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen

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.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Simbec Orion Ltd

Merthyr Tydfil, CF48 4DR, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

Ibuprofen Lysine

Drug

Ibuprofen-LDH

Drug

Primary outcomes

  1. Cmax

    Time frame: 12 hours

  2. AUC(0-inf)

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

Oxford Pharmascience Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 28, 2016
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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