Phase I Study PK Study With OXP005 and Naprosyn

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.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical Ltd

Nottingham, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OXP005

Drug

Other names: Naproxen

Naprosyn®

Drug

Other names: Naproxen

Primary outcomes

Comparative bioavailability of naproxen as measured by Tmax, Cmax, AUC, half-life

Time frame: Day 1 & Day 8 single dose crossover

Sponsors and collaborators

Lead sponsor

Oxford Pharmascience Ltd

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jan 30, 2015
Registry last updated: Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed