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The purpose of this study is to determine the pharmacokinetic (PK) parameters of vortioxetine after single and multiple oral dosing to healthy Chinese men and women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine 10 mg single dose | Experimental | 8 men and 8 women |
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| Vortioxetine 20 mg single dose | Experimental | 8 men and 8 women |
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| Vortioxetine 10 mg multiple dose | Experimental | 8 men and 8 women |
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| Vortioxetine 20 mg multiple dose | Experimental | 8 men and 8 women |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine 10 mg single dose | Drug | 10 mg tablet for oral use, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of vortioxetine and its metabolites: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio | Composite pharmacokinetic outcome measures (PK parameters: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio) | Day 1 to 312 hours post-dose |
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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 |
|---|---|---|---|---|---|---|
| CB801 | Chengdu | China |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Vortioxetine 20 mg single dose | Drug | Two 10 mg tablets for oral use, single dose, |
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| Vortioxetine 10 mg multiple dose | Drug | 10 mg tablet for oral use once, daily for 14 days. |
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| Vortioxetine 20 mg multiple dose | Drug | Two 10 mg tablets for oral use, once daily for 14 days. |
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