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| ID | Type | Description | Link |
|---|---|---|---|
| EudractCT 2008-006553-40 |
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The aim of this study is to relate pharmacokinetics of two different formulations of quetiapine to PET measured receptor occupancy in the brains of healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEROQUEL XR (quetiapine) | Drug | repeated dose of oral tablets, 8 times per subject |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Positron emission tomography using the radioligand [11C]raclopride | 5 visits |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs), vital signs and changes in laboratory parameters, physical examinations, Alertness Visual Analogue Scale. | 5 visits. Some tests will be done several times per visit. All tests will not be performed at every visit. | |
| Pharmacokinetics of quetiapine and its main active metabolite |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingemar Bylesjö, MD, PhD | AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden | Principal Investigator |
| Sophia Bengtsson | AstraZeneca R&D, Södertälje, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21477416 | Derived | Nord M, Nyberg S, Brogren J, Jucaite A, Halldin C, Farde L. Comparison of D(2) dopamine receptor occupancy after oral administration of quetiapine fumarate immediate-release and extended-release formulations in healthy subjects. Int J Neuropsychopharmacol. 2011 Nov;14(10):1357-66. doi: 10.1017/S1461145711000514. Epub 2011 Apr 11. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| SEROQUEL IR (quetiapine) |
| Drug |
repeated dose of oral tablets, 4 times per subject |
|
| radioligand [11C]raclopride | Drug | single dose of iv admin, 5 times per subject |
|
| 22 samples |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |