Overview

Phase I Study PK Study With OXP005 and Naprosyn

Status:
Completed

Trial end date:
2015-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Oxford Pharmascience Ltd

Treatments:

Naproxen

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