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

H. Lundbeck A/S40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Women

Interventions

Encapsulated vortioxetine IR tablet, 20 mgDRUG

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)

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy women ≥18 and ≤45 years of age with a body mass index (BMI) of \>18.5 and \<30.0 kg/m2. * Women will be of child-bearing potential with a confirmed non-pregnant and non-lactating status. Other protocol-defined Inclusion and Exclusion Criteria may apply.

Locations (1)

GB801

London, United Kingdom

Outcomes

Primary Outcomes

Gastro-intestinal tolerability (nausea) measured with 11-point Numerical Rating Scale

Time frame: Up to 24 hours post-dose in each treatment period

Gastro-intestinal tolerability (abdominal pain) measured with 11-point Numerical Rating Scale

Time frame: Up to 24 hours post-dose in each treatment period

Gastro-intestinal tolerability (abdominal discomfort) measured with 11-point Numerical Rating Scale

Time frame: Up to 24 hours post-dose in each treatment period

Frequency, severity and duration of reported gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort and abdominal pain)

Time frame: Up to 72 hours post-dose in each treatment period

Area under the vortioxetine plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)

Time frame: Up to 72 hours postdose

Maximum observed concentration (Cmax) of vortioxetine

Time frame: Up to 72 hours postdose

Nominal time corresponding to the occurrence of Cmax (tmax)

Time frame: Up to 72 hours postdose

Data from ClinicalTrials.gov

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