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To investigate whether there is a food-effect with oral administration with EB-1020 as well as to obtain information on the safety, and tolerability of EB-1020 in a range of doses.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EB-1020 SR1 | Active Comparator | Sustained release formulation |
|
| EB-1020 SR2 | Active Comparator | Sustained Release Formulation |
|
| EB-1020 SR3 | Active Comparator | Sustained Release Formulation |
|
| EB-1020 IR | Active Comparator | Immediate Release Formulation |
|
| Placebo | Placebo Comparator | Placebo Formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EB-1020 IR | Drug | Immediate release |
| |
| EB-1020 SR1 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Pharmacokinetic parameters | up to 6 months |
| Tmax | Pharmacokinetic parameter | up to 6 months |
| AUC | Pharmacokinetic parameter | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of food on Cmax | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Ltd. | Melbourne | Victoria | 3004 | Australia |
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| Label | URL |
|---|---|
| Otsuka Clinical Trial Website | View source |
| Otsuka Clinical Trial Transparency | View source |
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| Drug |
sustained release |
|
| EB-1020 SR2 | Drug | Sustained release |
|
| EB-1020 SR3 | Drug | Sustained release |
|
| Placebo | Other | Placebo formulation |
|