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A repeat dose pharmacokinetic study investigating two paracetamol formulations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental paracetamol formulation | Experimental | test formulation |
|
| Marketed paracetamol | Active Comparator | Marketed paracetamol |
|
| Higher dose marketed paracetamol | Active Comparator | higher dose marketed paracetamol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental paracetamol formulation | Drug | experimental |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence as measured by Area Under the Curve (AUC) | last 24 hours of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Time duration at or above minimal therapeutic plasma paracetamol concentration | last 24 hours of dosing | |
| To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel) | last 24 hours of dosing | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MDS Pharma Services NEBRASKA | Lincoln | Nebraska | 68501 | United States |
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| Marketed paracetamol |
| Drug |
Marketed paracetamol |
|
| Higher dose marketed paracetamol | Drug | Higher dose marketed paracetamol |
|
| Adverse events |
| Baseline to 72 hours post dosing |