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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001335-39 | EudraCT Number |
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The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AF35700 5 mg clinical formulation | Experimental |
| |
| Lu AF35700 5 mg commercial formulation | Experimental |
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| Lu AF35700 10 mg clinical formulation | Experimental |
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| Lu AF35700 10 mg commercial formulation | Experimental |
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| Lu AF35700 20 mg clinical formulation | Experimental |
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| Lu AF35700 20 mg commercial formulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF35700 5 mg clinical formulation | Drug | Lu AF35700 tablets 5 mg oral single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-72h of Lu AF35700 | Area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h) | zero to 72 hours |
| Cmax of Lu AF35700 | Maximum observed plasma concentration (Cmax) of Lu AF35700 | zero to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of Lu AF35700 | Time to occurance of Cmax of Lu AF35700 | zero to 72 hours |
| AUC0-t of Lu AF35700 | Area under the Lu AF35700 concentration-time curve from zero to time of the last quantifiable plasma concentration |
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Inclusion Criteria:
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 |
|---|---|
| C000726227 | Lu AF35700 |
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| Lu AF35700 5 mg commercial formulation | Drug | Lu AF35700 tablets 5 mg oral single dose |
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| Lu AF35700 10 mg clinical formulation | Drug | Lu AF35700 tablets 10 mg oral single dose |
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| Lu AF35700 10 mg commercial formulation | Drug | Lu AF35700 tablets 10 mg oral single dose |
|
| Lu AF35700 20 mg clinical formulation | Drug | Lu AF35700 tablets 20 mg oral single dose |
|
| Lu AF35700 20 mg commercial formulation | Drug | Lu AF35700 tablets 20 mg oral single dose |
|
| zero to time of the last quantifiable plasma concentration |