Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women
NCT ID: NCT02386488
Last Updated: 2015-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2015-03-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vortioxetine 10 mg single dose
8 men and 8 women
Vortioxetine 10 mg single dose
10 mg tablet for oral use, single dose
Vortioxetine 20 mg single dose
8 men and 8 women
Vortioxetine 20 mg single dose
Two 10 mg tablets for oral use, single dose,
Vortioxetine 10 mg multiple dose
8 men and 8 women
Vortioxetine 10 mg multiple dose
10 mg tablet for oral use once, daily for 14 days.
Vortioxetine 20 mg multiple dose
8 men and 8 women
Vortioxetine 20 mg multiple dose
Two 10 mg tablets for oral use, once daily for 14 days.
Interventions
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Vortioxetine 10 mg single dose
10 mg tablet for oral use, single dose
Vortioxetine 20 mg single dose
Two 10 mg tablets for oral use, single dose,
Vortioxetine 10 mg multiple dose
10 mg tablet for oral use once, daily for 14 days.
Vortioxetine 20 mg multiple dose
Two 10 mg tablets for oral use, once daily for 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between 18 and 45 years of age (extremes included)
* BMI between 18.5 and 24 kg/m2 (extremes included)
* Body weight ≥45 kg.
Exclusion Criteria
* Previously been dosed with vortioxetine
* The subject has taken any investigational medicinal products within 3 months prior to the first dose of IMP (investigational medicinal product)
18 Years
45 Years
ALL
Yes
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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CB801
Chengdu, , China
Countries
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Other Identifiers
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16060A
Identifier Type: -
Identifier Source: org_study_id
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