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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000405-37 | EudraCT Number |
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The study was withdrawn based on new efficacy data from another study
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The purpose of this study is to investigate whether 2 different tablet compositions are similar regarding absorption (uptake) in the body. One composition was used in the clinical development program and the other is intended for the market
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Reference | Experimental | Single dose of commercial tablet Treatment A (Test) in period I. Followed by single dose of clinical tablet Treatment B (Reference) in period II. First and second dose administration will be separated by a washout period of at least 7 days |
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| Reference/Test | Experimental | Single dose of clinical tablet Treatment B (Reference) in period I. Followed by single dose of commercial tablet Treatment A (Test) in period II. First and second dose administration will be separated by a washout period of at least 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idalopirdine commercial tablet (test) | Drug | single dose, 10 mg, oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the idalopirdine plasma concentration-time curve (AUC0-t) from time zero to the last quantifiable concentration post-dose | baseline to 72 hours post-dose | |
| Maximum observed concentration of idalopirdine (Cmax) | baseline to 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to occurrence of Cmax (tmax) | baseline to 72 hours post-dose | |
| Area under the idalopirdine plasma concentration-time curve (AUC0-inf) from time zero to infinity | baseline to 72 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| GB1050 | Leeds | United Kingdom |
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| Idalopirdine clinical tablet (reference) | Drug | single dose, 10 mg, oral |
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| Apparent elimination half-life (t1/2) | baseline to 72 hours post-dose |