Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women

H. Lundbeck A/S64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pharmacokinetics

Interventions

Vortioxetine 10 mg single doseDRUG

10 mg tablet for oral use, single dose

Vortioxetine 20 mg single doseDRUG

Two 10 mg tablets for oral use, single dose,

Vortioxetine 10 mg multiple doseDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy young Chinese men or women * 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: * Pregnant or lactating. * 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) Other protocol defined inclusion and exclusion criteria may apply

Locations (1)

CB801

Chengdu, China

Outcomes

Primary Outcomes

Pharmacokinetics (PK) of vortioxetine and its metabolites: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio

Composite pharmacokinetic outcome measures (PK parameters: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio)

Time frame: Day 1 to 312 hours post-dose

Data from ClinicalTrials.gov

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