Phase I Study PK Study With OXP005 and Naprosyn

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Pharmacokinetics

Study Groups

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OXP005

Group Type EXPERIMENTAL

OXP005

Intervention Type DRUG

Naproxen

Group Type ACTIVE_COMPARATOR

Naprosyn®

Intervention Type DRUG

Interventions

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OXP005

Intervention Type DRUG

Naprosyn®

Intervention Type DRUG

Other Intervention Names

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Naproxen Naproxen

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes