NCT02112903

Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women

Interventional, Randomised, Double-blind 4-way Crossover Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort, and abdominal pain) of vortioxetine following single oral doses of three modified-release (MR) capsules with differently coated multiple particles compared to one immediate-release (IR) tablet.

Conditions

• Healthy Women

Interventions

Type	Name	Description
DRUG	Encapsulated vortioxetine IR tablet, 20 mg
DRUG	Vortioxetine MR capsule 20 mg (pH 5.5)
DRUG	Vortioxetine MR capsule 20 mg (pH 6.0)
DRUG	Vortioxetine MR capsule 20 mg (pH 7.0)

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-09-01
• First posted: 2014-04-14
• Last updated: 2014-11-13

Locations

1 site across 1 country: United Kingdom