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Phase I Study PK Study With OXP005 and Naprosyn

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oxford Pharmascience Ltd
ClinicalTrials.gov Identifier:
NCT02351024
First received: January 21, 2015
Last updated: March 31, 2015
Last verified: March 2015
  Purpose
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 Intervention Phase
Pharmacokinetics
Drug: OXP005
Drug: Naprosyn®
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Oxford Pharmascience Ltd:

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

Study Start Date: February 2015
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OXP005 Drug: OXP005
Other Name: Naproxen
Active Comparator: Naproxen Drug: Naprosyn®
Other Name: Naproxen

  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 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
  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: NCT02351024

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

Responsible Party: Oxford Pharmascience Ltd
ClinicalTrials.gov Identifier: NCT02351024     History of Changes
Other Study ID Numbers: OXP005-001
Study First Received: January 21, 2015
Last Updated: March 31, 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

ClinicalTrials.gov processed this record on April 24, 2017