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| Name | Class |
|---|---|
| Quotient Clinical | OTHER |
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The study will compare the study drug to an already marketed formulation of prescription strength ibuprofen (Brufen® 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 consist of 2 parts involving up to 54 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product. Part 1 will be a cross over study in which up to 10 subjects will receive a single dose of 800 mg study drug OXP001 or Brufen® on Day 1, then a single dose of 800 mg study drug OXP001 or Brufen® on Day 4. Part 1 will assess bioavailability and involve an interim decision on progression to Part 2. In Part 2, up to 44 subjects will receive a dose of 800 mg OXP001 or Brufen® three times daily for 7 days in order to assess pharmacokinetics and stomach irritation using endoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 OXP001 | Experimental | OXP001 formulation containing 800mg ibuprofen single dose |
|
| Part 1 Ibuprofen control | Active Comparator | Ibuprofen control 800mg single dose |
|
| Part 2 OXP001 | Experimental | OXP001 formulation containing 800mg ibuprofen three times per day |
|
| Part 2 Ibuprofen control | Experimental | Ibuprofen control 800mg three times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Comparison of Peak Plasma Concentration (Cmax) | Part 1; Day 1 and Day 4 | |
| Part 2: Comparison of Average Lanza Score | Part 2; Day 8 | |
| Part 2: Comparison of Average Number of Erosions | Day 8 | |
| Part 1: Comparison of Area Under the Curve (AUC) | Part 1; Day 1 and Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Mair | Quotient Clinical Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical Ltd | Nottingham | Notts | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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