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Phase I Study PK Study With OXP005 and Naprosyn

Information source: Oxford Pharmascience Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics

Intervention: OXP005 (Drug); Naprosyn® (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Oxford Pharmascience Ltd

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.

Clinical Details

Official title: Study to Assess the Comparative Bioavailability and Pharmacokinetics of Naproxen From OXP005 Tablets (Test) And Naprosyn« Tablets (Reference) in Normal, Healthy, Adult Subjects

Study design: N/A

Primary outcome: Comparative bioavailability of naproxen as measured by Tmax, Cmax, AUC, half-life

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

Quotient Clinical Ltd, Nottingham, United Kingdom
Additional Information

Starting date: February 2015
Last updated: March 31, 2015

Page last updated: August 23, 2015

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