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The purpose of this study is to establish bioequivalence of flupentixol/meltracen, between a new film-coated tablet formulation and the marketed coated tablet formulation (Deanxit®), administered single dose in fasted and fed condition
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1 Fasted condition | Experimental | Subjects in cohort A1 will be administered the Investigational Medicinal Product in a fasted state, 30 subjects per cohort |
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| Cohort A2 Fed condition | Experimental | Subjects in cohort A2 will be administered the Investigational Medicinal Product in a fed state, 30 subjects per cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| test treatment: flupentixol/melitracen | Drug | 0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0-72h: flupentixol | the area under the flupentixol plasma concentration-time curve | from zero to 72 hours post-dose |
| Cmax: flupentixol | maximum observed plasma concentration of flupentixol | from zero to 72 hours post-dose |
| AUC0-72h: melitracen | the area under the melitracen plasma concentration-time curve | from zero to 72 hours post-dose |
| Cmax: melitracen | maximum observed concentration of melitracen | from zero to 72 hours post-dose |
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Inclusion 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 |
|---|---|---|---|---|---|---|
| CN1036 Shijitan Hospital | Beijing | China |
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| ID | Term |
|---|---|
| C000851 | flupentixol, melitracen drug combination |
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| reference treatment: flupentixol/melitracen | Drug | 0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose |
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