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The purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: 3 way crossover | Experimental | AZD1305: ER test formulation 1 (w/wo food) and reference formulation |
|
| Part B1: single arm | Experimental | AZD1305: ER test formulation 1 |
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| Part B2: 3 way crossover | Experimental | AZD1305: ER test formulation 2 (w/wo food) and reference formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1305 | Drug | Single Oral Dose, ER formulation 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma | From predose until 48 hours post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events, ECG variables, vital signs, physical examination, laboratory variables and weight | Frequent safety measurements during the study, from screening period to follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Lunde | AstraZeneca R&D, Mölndal, Sweden | Study Director |
| Klaus Francke | PAREXEL Early Phase Clinical Unit, London UK. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Harrow | United Kingdom |
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| ID | Term |
|---|---|
| C550721 | tert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamate |
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| AZD1305 |
| Drug |
ER formulation 1, bid for 5 days |
|
| AZD1305 | Drug | Single Oral Dose, ER formulation 2 |
|