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CompletedNCT01676571Updated Jan 16, 2013

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

A Phase 1 interventional study of Lu AA21004 in Healthy, sponsored by H. Lundbeck A/S. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-16.

Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 224 studies on the registry; 9 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Browse H. Lundbeck A/S studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Lu AA21004

    Drug: Lu AA21004

Interventions

  • DrugLu AA21004

    10 mg immediate-release (IR), one single dose, orally

    Also known as: Vortioxetine

06

What researchers measure

Primary outcomes

  1. PK AUC determination of Lu AA21004 (Vortioxetine)

    Area under the curve (AUC)

    Time frame: 11 days

  2. PK Cmax determination of Lu AA21004 (Vortioxetine)

    Maximum observed concentration (Cmax)

    Time frame: 11 days

Other outcomes

  1. PK MR determination of metabolites Lu AA34443 and Lu AA39835

    Metabolic ratio (MR)

    Time frame: 11 days

  2. Number of patients with adverse events as a measure of safety and tolerability

    Time frame: 11 days

07

Study locations

1 site
  • CN001
    Tianjin, 300457, China
08

References and documents

Publications

  • 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. PubMed 31552551 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01676571
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Aug 31, 2012
Start date
Oct 2012
Primary completion
Nov 2012
Last update
Jan 16, 2013

Study contacts

Email contact via H. Lundbeck A/S
study director · LundbeckClinicalTrials@lundbeck.com

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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