Pharmacokinetic Properties of Lu AA21004 (Vortioxetine) in Healthy Young Chinese Men and Women

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lu AA21004

Study type: Interventional

Funder types: Industry

Identifiers

NCT01676571

14077A

Details and patient eligibility

About

The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu AA21004 (Vortioxetine) in the Chinese population.

Enrollment: 16 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Lu AA21004

Experimental group

Treatment:

Drug: Lu AA21004