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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy Women

Treatments: 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); Drug: Encapsulated vortioxetine IR tablet, 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02112903

15947A

2014-000121-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 4 patient groups

Encapsulated vortioxetine IR tablet, 20 mg

Experimental group

Description:

Single oral dose

Treatment:

Drug: Encapsulated vortioxetine IR tablet, 20 mg

Vortioxetine MR capsule 20 mg (pH 5.5)

Experimental group

Description:

Single oral dose

Treatment:

Drug: Vortioxetine MR capsule 20 mg (pH 5.5)

Vortioxetine MR capsule 20 mg (pH 6.0)

Experimental group

Description:

Single oral dose

Treatment:

Drug: Vortioxetine MR capsule 20 mg (pH 6.0)

Vortioxetine MR capsule 20 mg (pH 7.0)

Experimental group

Description:

Single oral dose

Treatment:

Drug: Vortioxetine MR capsule 20 mg (pH 7.0)