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Phase I Study PK Study With OXP005 and Naprosyn

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. Identifier: NCT02351024
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : April 1, 2015
Information provided by (Responsible Party):
Oxford Pharmascience Ltd

Brief Summary:
The Sponsor is developing a new form of naproxen (the study drug, OXP005), for the potential treatment of rheumatic and painful conditions. The study will compare the study drug to an already marketed formulation of prescription strength naproxen (Naprosyn® the reference product) by looking at how a single dose of the drug is taken up by the body. The safety and tolerability of the drug will also be assessed.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: OXP005 Drug: Naprosyn® Phase 1

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Study Type : Interventional  (Clinical Trial)
Official Title: Study to Assess the Comparative Bioavailability and Pharmacokinetics of Naproxen From OXP005 Tablets (Test) And Naprosyn® Tablets (Reference) in Normal, Healthy, Adult Subjects
Study Start Date : February 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: OXP005 Drug: OXP005
Other Name: Naproxen

Active Comparator: Naproxen Drug: Naprosyn®
Other Name: Naproxen

Primary Outcome Measures :
  1. Comparative bioavailability of naproxen as measured by Tmax, Cmax, AUC, half-life [ Time Frame: Day 1 & Day 8 single dose crossover ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Healthy male subjects and non-pregnant, non breast feeding healthy female subjects aged 18 to 55 years
  • Body mass index 18.0 to 30.0 kg/m2

Exclusion Criteria:

  • History of or current significant diseases or conditions including any disease or condition affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, central nervous, immunological, dermatological, gastrointestinal or any other body system

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 identifier (NCT number): NCT02351024

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United Kingdom
Quotient Clinical Ltd
Nottingham, United Kingdom
Sponsors and Collaborators
Oxford Pharmascience Ltd

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Responsible Party: Oxford Pharmascience Ltd Identifier: NCT02351024    
Other Study ID Numbers: OXP005-001
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action