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A single dose pharmacokinetic study investigating two paracetamol formulations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marketed paracetamol | Active Comparator | marketed formulation |
|
| Experimental paracetamol formulation | Experimental | Experimental formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed paracetamol | Drug | Marketed formulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To compare bioavailability as measured by Area under the Curve in both fed and fasted states | Visit 1 through Visit 3 (Day 13) | |
| To assess the effect of food on extent and rate of paracetamol absorption as measured by Area Under the Curve and Cmax | Visit 1 through Visit 3 (Day 13) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess descriptive pharmacokinetic characteristics (Tmax, T1/2, AUC, Cmax) | Visit 1 through Visit 3 (Day 13) |
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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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| Experimental paracetamol formulation |
| Drug |
Experimental formulation |
|