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This study will compare the tolerability of Quetiapine Fumarate immediate release formulation and Quetiapine Fumarate extended release formulation during initial dose escalation in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Quetiapine Fumarate Immediate Release |
|
| 2 | Experimental | Quetiapine Fumarate Extended Release |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine Fumarate | Drug | Tablet, Oral, once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) 1 hour post dose at Day 1 | 1 hour after dose administration at the first dosing day (i.e. Day 1) of each period | |
| Area under the VAS-time curve | Calculated daily from the 13 assessments for 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic relationship between maximum VAS and PK concentration | On last day of period (Day 5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Datto, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baltimore | Maryland | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19393840 | Derived | Datto C, Berggren L, Patel JB, Eriksson H. Self-reported sedation profile of immediate-release quetiapine fumarate compared with extended-release quetiapine fumarate during dose initiation: a randomized, double-blind, crossover study in healthy adult subjects. Clin Ther. 2009 Mar;31(3):492-502. doi: 10.1016/j.clinthera.2009.03.002. |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| Quetiapine Fumarate | Drug | Tablet, Oral, once daily |
|
|
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |