Study Results
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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COMPLETED
PHASE1
43 participants
INTERVENTIONAL
2014-02-28
2014-04-30
Brief Summary
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This study will compare the study drug to an already marketed formulation of prescription strength Ibuprofen (the reference product) by looking at how the drug is taken up by the body and also by performing a specialist procedure called an endoscopy (or more specifically a gastroscopy). The safety and tolerability of the study drug will also be assessed.
The study will involve approximately 44 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product for 8 days. On Day 1, subjects will receive a single 800 mg dose of ibuprofen. On Days 2 to 9, subjects will receive 800 mg ibuprofen three times a day.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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OXP001
OXP001
OXP001
Ibuprofen
Brufen
Ibuprofen
Interventions
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OXP001
Ibuprofen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 18-55 years
* Normal, healthy upper gastrointestinal tract
Exclusion Criteria
* History of allergy to non-steroidal anti-inflammatory drugs (NSAIDs)
18 Years
55 Years
ALL
Yes
Sponsors
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Oxford Pharmascience Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Stuart Mair, MB ChB
Role: PRINCIPAL_INVESTIGATOR
Quotient Clinical Ltd
Locations
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Quotient Clinical
Nottingham, , United Kingdom
Countries
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Other Identifiers
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OXP001-002
Identifier Type: -
Identifier Source: org_study_id