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Completed

NCT Number: 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

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.

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Key information

Conditions

Healthy Women

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

GB801

London, NW10 7EW, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Drug

Primary outcomes

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

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

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

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

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

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

  4. 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

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

    Time frame: Up to 72 hours postdose

  6. Maximum observed concentration (Cmax) of vortioxetine

    Time frame: Up to 72 hours postdose

  7. Nominal time corresponding to the occurrence of Cmax (tmax)

    Time frame: Up to 72 hours postdose

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
First posted
Apr 14, 2014
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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