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
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