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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCt nr 2007-007128-16 |
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The purpose of the study is to evaluate if AZD3355 and Nexium interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD3355 150 mg |
|
| 2 | Experimental | Esomeprazole 40mg |
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| 3 | Experimental | AZD3355 150mg/Esomeprazole 40mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3355 | Drug | 150 mg bid, oral, 7 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| PK variables | Frequent sampling occasions during day 7 each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 4-BOH cholesterol | Sampling occasions during day 7 one treatment period (AZD3355 alone) | |
| Safety variables (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 |
| Jan Vouis, MD | Quintiles AB, Uppsala, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Uppsala | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21171670 | Derived | Niazi M, Silberg DG, Miller F, Ruth M, Holmberg AA. Evaluation of the pharmacokinetic interaction between lesogaberan (AZD3355) and esomeprazole in healthy subjects. Drugs R D. 2010;10(4):243-51. doi: 10.2165/11588180-000000000-00000. |
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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 |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Esomeprazole | Drug | 40 mg od, oral, 7 days |
|
|
| D004066 | Digestive System Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |