Pharmacokinetics
Conditions
Brief 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.
Interventions
DRUGVortioxetine 10 mg single dose
10 mg tablet for oral use, single dose
DRUGVortioxetine 20 mg single dose
Two 10 mg tablets for oral use, single dose,
DRUGVortioxetine 10 mg multiple dose
10 mg tablet for oral use once, daily for 14 days.
DRUGVortioxetine 20 mg multiple dose
Two 10 mg tablets for oral use, once daily for 14 days.
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of vortioxetine and its metabolites: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio | Day 1 to 312 hours post-dose | Composite pharmacokinetic outcome measures (PK parameters: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio) |
Countries
China
Outcome results
None listed