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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 is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Oxford Pharmascience Ltd
Sponsor:
Information provided by (Responsible Party):
Oxford Pharmascience Ltd
ClinicalTrials.gov Identifier:
NCT02974361
First received: November 21, 2016
Last updated: March 1, 2017
Last verified: March 2017
  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: No masking
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 ]

Estimated Enrollment: 30
Study Start Date: December 2016
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: April 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02974361

Contacts
Contact: Sheryl Caswell +44 (0)20 7554 5875 sheryl.caswell@pharmascience.co.uk

Locations
United Kingdom
Simbec Orion Ltd Recruiting
Merthyr Tydfil, United Kingdom, CF48 4DR
Contact: Sheryl Caswell    +44 (0)20 7554 5875    sheryl.caswell@pharmascience.co.uk   
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
Study First Received: November 21, 2016
Last Updated: March 1, 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

ClinicalTrials.gov processed this record on April 26, 2017