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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001799-69 | EudraCT Number |
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This study aims to establish bioequivalence between two tablet formulations of idalopirdine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idalopirdine 60 mg formulation A (test) | Experimental |
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| Idalopirdine 60 mg formulation B (reference) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idalopirdine 60 mg formulation A (test) | Drug | Tablet for oral use, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the idalopirdine plasma concentration-time curve | 0 to 72 hours post-dose | |
| maximum observed concentration (Cmax) of idalopirdine | 0 to 72 hours post-dose |
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Inclusion Criteria:
Healthy men and women
-≥18 and ≤55 years of age
body mass index (BMI) of >18.5 and <30 kg/m2
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance | Leeds | United Kingdom |
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| ID | Term |
|---|---|
| C568612 | (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine |
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| Idalopirdine 60 mg formulation B (reference) | Drug | Tablet for oral use, single dose |
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