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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000121-20 | EudraCT Number |
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The purpose of this study is to evaluate the gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort, and abdominal pain) of vortioxetine following single oral doses of three modified-release (MR) capsules with differently coated multiple particles compared to one immediate-release (IR) tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Encapsulated vortioxetine IR tablet, 20 mg | Experimental | Single oral dose |
|
| Vortioxetine MR capsule 20 mg (pH 5.5) | Experimental | Single oral dose |
|
| Vortioxetine MR capsule 20 mg (pH 6.0) | Experimental | Single oral dose |
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| Vortioxetine MR capsule 20 mg (pH 7.0) | Experimental | Single oral dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Encapsulated vortioxetine IR tablet, 20 mg | Drug |
| ||
| Vortioxetine MR capsule 20 mg (pH 5.5) |
| Measure | Description | Time Frame |
|---|---|---|
| Gastro-intestinal tolerability (nausea) measured with 11-point Numerical Rating Scale | Up to 24 hours post-dose in each treatment period | |
| Gastro-intestinal tolerability (abdominal pain) measured with 11-point Numerical Rating Scale | Up to 24 hours post-dose in each treatment period | |
| Gastro-intestinal tolerability (abdominal discomfort) measured with 11-point Numerical Rating Scale | Up to 24 hours post-dose in each treatment period | |
| Frequency, severity and duration of reported gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort and abdominal pain) | Up to 72 hours post-dose in each treatment period | |
| Area under the vortioxetine plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h) | Up to 72 hours postdose | |
| Maximum observed concentration (Cmax) of vortioxetine | Up to 72 hours postdose | |
| Nominal time corresponding to the occurrence of Cmax (tmax) | Up to 72 hours postdose |
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Inclusion 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 |
|---|---|---|---|---|---|---|
| GB801 | London | NW10 7EW | United Kingdom |
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| Drug |
|
| Vortioxetine MR capsule 20 mg (pH 6.0) | Drug |
|
| Vortioxetine MR capsule 20 mg (pH 7.0) | Drug |
|