Healthy
Conditions
Brief summary
The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu AA21004 (Vortioxetine) in the Chinese population.
Interventions
DRUGLu AA21004
10 mg immediate-release (IR), one single dose, orally
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject is a Chinese man or woman * The subject is, in the opinion of the investigator, generally healthy * If female, the subject must have a negative pregnancy test at screening and baseline, and agree not to try to become pregnant from Screening until after the Follow-up Visit
Exclusion criteria
* The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason. Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK AUC determination of Lu AA21004 (Vortioxetine) | 11 days | Area under the curve (AUC) |
| PK Cmax determination of Lu AA21004 (Vortioxetine) | 11 days | Maximum observed concentration (Cmax) |
Other
| Measure | Time frame | Description |
|---|---|---|
| PK MR determination of metabolites Lu AA34443 and Lu AA39835 | 11 days | Metabolic ratio (MR) |
| Number of patients with adverse events as a measure of safety and tolerability | 11 days | — |
Countries
China
Outcome results
None listed