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A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Paracetamol Tablet | Experimental | Experimental paracetamol tablet (500 milligrams [mg]) administered with 240 milliliters (mL) of water. |
|
| Standard Paracetamol Tablet (500 mg) | Active Comparator | Standard paracetamol tablet (500 mg) administered with 240 mL of water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | 500 mg immediate release paracetamol formulations |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC (0-inf) | Area under the plasma concentration time curve from zero and extrapolated to infinite time. | Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. |
| Cmax | Maximum plasma concentration of paracetamol. | Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. |
| AUC (0-t) | Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample. | Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time taken to reach maximum plasma concentration of paracetamol. | Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D005334 | Fever |
| D020773 | Headache Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| Aniline Compounds |
| D000588 | Amines |