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OpenTrials
Completed

NCT Number: NCT01676571

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

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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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CN001

Tianjin, 300457, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AA21004

Drug

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

Other names: Vortioxetine

Primary outcomes

  1. PK AUC determination of Lu AA21004 (Vortioxetine)

    Time frame: 11 days

    Area under the curve (AUC)

  2. PK Cmax determination of Lu AA21004 (Vortioxetine)

    Time frame: 11 days

    Maximum observed concentration (Cmax)

Other outcomes

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

    Time frame: 11 days

    Metabolic ratio (MR)

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

    Time frame: 11 days

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

A Single-centre, Open-label, Single-dose Interventional Study Investigating the Pharmacokinetic Properties of Lu AA21004 in Healthy Young Chinese Men and Women

Important dates

Study start
2012
Primary completion
2012
First posted
Aug 31, 2012
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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