Phase I Study PK Study With OXP005 and Naprosyn

Oxford Pharmascience

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetics

Treatments

Drug: OXP005

Drug: Naprosyn®

Study type

Interventional

Funder types

Industry

Identifiers

NCT02351024

OXP005-001

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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