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Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women

NCT02386488 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2015-05-19

No results posted yet for this study

Summary

The purpose of this study is to determine the pharmacokinetic (PK) parameters of vortioxetine after single and multiple oral dosing to healthy Chinese men and women.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Vortioxetine 10 mg single dose

10 mg tablet for oral use, single dose

DRUG

Vortioxetine 20 mg single dose

Two 10 mg tablets for oral use, single dose,

DRUG

Vortioxetine 10 mg multiple dose

10 mg tablet for oral use once, daily for 14 days.

DRUG

Vortioxetine 20 mg multiple dose

Two 10 mg tablets for oral use, once daily for 14 days.

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02386488 on ClinicalTrials.gov