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Phase I Study PK Study With OXP005 and Naprosyn

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ClinicalTrials.gov Identifier: NCT02351024
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : April 1, 2015
Sponsor:
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

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
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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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 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 ClinicalTrials.gov identifier (NCT number): NCT02351024


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

Responsible Party: Oxford Pharmascience Ltd
ClinicalTrials.gov Identifier: NCT02351024     History of Changes
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:
Naproxen
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
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action