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A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methylprednisolone suspension | Experimental |
| |
| methylprednisolone tablets | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylprednisolone | Drug | constituted powder for oral suspension 4 mg/mL single dose at 32 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf (area under the concentration time curve to infinity) | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | |
| Cmax (maximum concentration) | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast (area under the concentration time curve to last time point) | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | |
| Tmax (time at maximum concentration) | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D007863 | Lecithin Cholesterol Acyltransferase Deficiency |
| ID | Term |
|---|---|
| D052456 | Hypoalphalipoproteinemias |
| D007009 | Hypolipoproteinemias |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| methylprednisolone | Drug | tablets 32 mg single dose |
|
| Half-life | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |