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

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ClinicalTrials.gov Identifier: NCT02974361
Recruitment Status : Completed
First Posted : November 28, 2016
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Oxford Pharmascience Ltd

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 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 or disease Intervention/treatment Phase
Pharmacokinetics Drug: Ibuprofen Drug: Ibuprofen Lysine Drug: Ibuprofen-LDH Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : December 2016
Actual Primary Completion Date : April 28, 2017
Actual Study Completion Date : May 3, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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


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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

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

Responsible Party: Oxford Pharmascience Ltd
ClinicalTrials.gov Identifier: NCT02974361     History of Changes
Other Study ID Numbers: OAT-01
First Posted: November 28, 2016    Key Record Dates
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