Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women
Phase 1
Completed
- Conditions
- Pharmacokinetics
- Interventions
- Registration Number
- NCT02386488
- Lead Sponsor
- H. Lundbeck A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vortioxetine 20 mg multiple dose Vortioxetine 20 mg multiple dose 8 men and 8 women Vortioxetine 10 mg single dose Vortioxetine 10 mg single dose 8 men and 8 women Vortioxetine 10 mg multiple dose Vortioxetine 10 mg multiple dose 8 men and 8 women Vortioxetine 20 mg single dose Vortioxetine 20 mg single dose 8 men and 8 women
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CB801
🇨🇳Chengdu, China