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This PK study is designed to show bioequivalence between the study treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental paracetamol formulation | Experimental | experimental formulation |
|
| paracetamol marketed formulation | Active Comparator | Paracetamol marketed formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental paracetamol | Drug | experimental paracetamol with caffeine |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence | 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax) | 10 hours |
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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 ARIZONA | Phoenix | Arizona | 85044 | United States |
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| ID | Term |
|---|---|
| D018781 | Tension-Type Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Paracetamol marketed formulation | Drug | marketed formulation containing caffeine |
|
| D009422 | Nervous System Diseases |