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

NCT ID: NCT02112903

Last Updated: 2014-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Encapsulated vortioxetine IR tablet, 20 mg

Single oral dose

Group Type EXPERIMENTAL

Encapsulated vortioxetine IR tablet, 20 mg

Intervention Type DRUG

Vortioxetine MR capsule 20 mg (pH 5.5)

Single oral dose

Group Type EXPERIMENTAL

Vortioxetine MR capsule 20 mg (pH 5.5)

Intervention Type DRUG

Vortioxetine MR capsule 20 mg (pH 6.0)

Single oral dose

Group Type EXPERIMENTAL

Vortioxetine MR capsule 20 mg (pH 6.0)

Intervention Type DRUG

Vortioxetine MR capsule 20 mg (pH 7.0)

Single oral dose

Group Type EXPERIMENTAL

Vortioxetine MR capsule 20 mg (pH 7.0)

Intervention Type DRUG

Interventions

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Encapsulated vortioxetine IR tablet, 20 mg

Intervention Type DRUG

Vortioxetine MR capsule 20 mg (pH 5.5)

Intervention Type DRUG

Vortioxetine MR capsule 20 mg (pH 6.0)

Intervention Type DRUG

Vortioxetine MR capsule 20 mg (pH 7.0)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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GB801

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2014-000121-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15947A

Identifier Type: -

Identifier Source: org_study_id