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A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms and heat sensitivity in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 36 subjects receiving a specified volume of the active component AZD1386 in a single dose. |
|
| 2 | Placebo Comparator | 36 subjects receiving a specified volume of placebo in a single dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1386 | Drug | Oral solution fixed dose (95 mg given orally on two occasions) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| VAS, HPT | Visit 2-4 |
| Measure | Description | Time Frame |
|---|---|---|
| eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia | Visit 2-4 | |
| Vital signs, laboratory variables and adverse event each day throughout the study. paper printout ECG and/or digital ECG throughout the study. Pain evoked assessments visit 1-3 | Visit 1-5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agneta Berg | AstraZeneca R&D Södertälje | Study Chair |
| Ingemar Bylesjö | AstraZeneca R&D CPU Karolinska University Hospital, Stockholm | Principal Investigator |
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| ID | Term |
|---|---|
| C574562 | AZD1386 |
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| Placebo |
| Drug |
Oral solution fixed dose (95 mg given orally on two occasions) |
|
| Pharmacokinetics/Pharmacodynamics | Visit 2-4 |