Phase I Study PK Study With OXP005 and Naprosyn

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: OXP005; Drug: Naprosyn®

• Registration Number: NCT02351024
• Lead Sponsor: Oxford Pharmascience Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-01-30
• Study Start: 2015-02
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OXP005	OXP005	-
Naproxen	Naprosyn®	-

Primary Outcome Measures

Name	Time	Method
Comparative bioavailability of naproxen as measured by Tmax, Cmax, AUC, half-life	Day 1 & Day 8 single dose crossover

Trial Locations

Locations (1)

Quotient Clinical Ltd; 🇬🇧 Nottingham, United Kingdom