Phase I Study PK Study With OXP005 and Naprosyn

March 31, 2015 updated by: Oxford Pharmascience Ltd

Study to Assess the Comparative Bioavailability and Pharmacokinetics of Naproxen From OXP005 Tablets (Test) And Naprosyn® Tablets (Reference) in Normal, Healthy, Adult Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Naproxen
Drug: Naprosyn®
Other Names:
  • Naproxen
Experimental: OXP005
Drug: OXP005
Other Names:
  • Naproxen

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford Pharmascience Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 21, 2015

First Submitted That Met QC Criteria

January 29, 2015

First Posted (Estimate)

January 30, 2015

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXP005-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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