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This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast dissolution suspension | Experimental |
| |
| Medium dissolution suspension | Experimental |
| |
| Slow dissolution suspension | Experimental |
| |
| Marketed suspension | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol fast dissolution suspension | Drug |
| ||
| Paracetamol medium dissolution suspension |
| Measure | Description | Time Frame |
|---|---|---|
| Time to plasma level above therapeutic level | baseline to 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| General PK parameters (e.g. AUC, Tmax, Cmax) | baseline to 8 hours |
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Inclusion 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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| Drug |
|
| Paracetamol slow dissolution suspension | Drug |
|
| Paracetamol | Drug |
|
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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