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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000431-17 | EudraCT Number |
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To establish bioequivalence of flupentixol/melitracen between a new film-coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen and the marketed coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen (Deanxit®), administered as single doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flupentixol/melitracen film-coated tablet | Experimental | test treatment - 0.5 mg/10 mg; oral as a single dose |
|
| Flupentixol/melitracen coated tablet (Deanxit®) | Other | reference treatment - 0.5 mg/10 mg, oral as a single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flupentixol/melitracen film-coated tablet | Drug |
| ||
| Flupentixol/melitracen coated tablet (Deanxit®) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the flupentixol plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h) | Up to 72 hours post dose | |
| Maximum observed concentration (Cmax) of flupentixol | Up to 312 hours post dose | |
| Area under the melitracen plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h) | Up to 72 hours post dose | |
| Maximum observed concentration (Cmax) of melitracen | Up to 312 hours post dose |
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Leeds | LS2 9LH | United Kingdom |
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| Drug |
|
| ID | Term |
|---|---|
| D005475 | Flupenthixol |
| C000851 | flupentixol, melitracen drug combination |
| ID | Term |
|---|---|
| D013892 | Thioxanthenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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