Pharmacokinetic Properties of Lu AA21004 (Vortioxetine) in Healthy Young Chinese Men and Women
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Lu AA21004
- Registration Number
- NCT01676571
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu AA21004 (Vortioxetine) in the Chinese population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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 exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lu AA21004 Lu AA21004 -
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CN001
🇨🇳Tianjin, China