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The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu AA21004 (Vortioxetine) in the Chinese population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AA21004 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AA21004 | Drug | 10 mg immediate-release (IR), one single dose, orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK AUC determination of Lu AA21004 (Vortioxetine) | Area under the curve (AUC) | 11 days |
| PK Cmax determination of Lu AA21004 (Vortioxetine) | Maximum observed concentration (Cmax) | 11 days |
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| Measure | Description | Time Frame |
|---|---|---|
| PK MR determination of metabolites Lu AA34443 and Lu AA39835 | Metabolic ratio (MR) | 11 days |
| Number of patients with adverse events as a measure of safety and tolerability | 11 days |
Inclusion Criteria:
Exclusion Criteria:
Other 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 |
|---|---|---|---|---|---|---|
| CN001 | Tianjin | 300457 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31552551 | Derived | Miao J, Wang G, Hou J, Areberg J, Zhao Y, Hojer AM, Ettrup A. Pharmacokinetics and Safety of Vortioxetine in the Chinese Population. Adv Ther. 2019 Nov;36(11):3134-3146. doi: 10.1007/s12325-019-01092-4. Epub 2019 Sep 24. |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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