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NCT02351024 Clinical Trial

Phase I Study PK Study With OXP005 and Naprosyn

Pharmacokinetics 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02351024
Other study ID # OXP005-001
Secondary ID
Status Completed
Phase Phase 1
First received January 21, 2015
Last updated March 31, 2015
Start date February 2015
Est. completion date March 2015

Study information
Verified date March 2015
Source Oxford Pharmascience Ltd
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• OXP005

• Naprosyn®

Locations
Country Name City State
United Kingdom Quotient Clinical Ltd Nottingham

Sponsors (1)
Lead Sponsor Collaborator
Oxford Pharmascience Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparative bioavailability of naproxen as measured by Tmax, Cmax, AUC, half-life Day 1 & Day 8 single dose crossover
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