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

January 15, 2013 updated by: H. Lundbeck A/S

A Single-centre, Open-label, Single-dose Interventional Study Investigating the Pharmacokinetic Properties of Lu AA21004 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China, 300457
        • CN001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lu AA21004
Drug: Lu AA21004
10 mg immediate-release (IR), one single dose, orally
Other Names:
  • Vortioxetine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK AUC determination of Lu AA21004 (Vortioxetine)
Time Frame: 11 days
Area under the curve (AUC)
11 days
PK Cmax determination of Lu AA21004 (Vortioxetine)
Time Frame: 11 days
Maximum observed concentration (Cmax)
11 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK MR determination of metabolites Lu AA34443 and Lu AA39835
Time Frame: 11 days
Metabolic ratio (MR)
11 days
Number of patients with adverse events as a measure of safety and tolerability
Time Frame: 11 days
11 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

August 29, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (Estimate)

August 31, 2012

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14077A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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