Phase I Study PK Study With OXP005 and Naprosyn
Study to Assess the Comparative Bioavailability and Pharmacokinetics of Naproxen From OXP005 Tablets (Test) And Naprosyn® Tablets (Reference) in Normal, Healthy, Adult Subjects
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2015
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2015
CompletedFirst Posted
Study publicly available on registry
January 30, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedApril 1, 2015
March 1, 2015
28 days
January 21, 2015
March 31, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Comparative bioavailability of naproxen as measured by Tmax, Cmax, AUC, half-life
Day 1 & Day 8 single dose crossover
Study Arms (2)
OXP005
EXPERIMENTALNaproxen
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quotient Clinical Ltd
Nottingham, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2015
First Posted
January 30, 2015
Study Start
February 1, 2015
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
April 1, 2015
Record last verified: 2015-03