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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT nr 2007-007126-22 |
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The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | IR Formulation 65 mg |
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| 2 | Experimental | IR Formulation 150 mg |
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| 3 | Experimental | MR formulation, 1h 65 mg |
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| 4 | Experimental | MR Formulation, 1h 150 mg |
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| 5 | Experimental | MR Formulation, 2h 150 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3355 | Drug | Single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Specific AE questions | During 0-4 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK variables | Frequent sampling up to 36 hours post dose | |
| Safety variables (other adverse events, blood pressure, pulse, safety lab) | During the whole treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Ersdal, PhD | AstraZeneca R&D, Mölndal, Sweden | Study Director |
| Aslak Rautio, MD | Quintiles Hermelinen, Varvsgatan 53, SE-972 33 Luleå, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Varvsgatan | Lulea | Sweden |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C545087 | lesogaberan |
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| D004066 | Digestive System Diseases |