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Trial record 1 of 1 for:    NCT02974361
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Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02974361
First Posted: November 28, 2016
Last Update Posted: May 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oxford Pharmascience Ltd
  Purpose

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.


Condition Intervention Phase
Pharmacokinetics Drug: Ibuprofen Drug: Ibuprofen Lysine Drug: Ibuprofen-LDH Phase 1

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

Resource links provided by NLM:


Further study details as provided by Oxford Pharmascience Ltd:

Primary Outcome Measures:
  • Cmax [ Time Frame: 12 hours ]
  • AUC(0-inf) [ Time Frame: 12 hours ]

Enrollment: 30
Study Start Date: December 2016
Study Completion Date: May 3, 2017
Primary Completion Date: April 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974361


Locations
United Kingdom
Simbec Orion Ltd
Merthyr Tydfil, United Kingdom, CF48 4DR
Sponsors and Collaborators
Oxford Pharmascience Ltd
Investigators
Principal Investigator: Annelize Koch Simbec Orion Ltd
  More Information

Responsible Party: Oxford Pharmascience Ltd
ClinicalTrials.gov Identifier: NCT02974361     History of Changes
Other Study ID Numbers: OAT-01
First Submitted: November 21, 2016
First Posted: November 28, 2016
Last Update Posted: May 3, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action