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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02112903

Enrollment

Registered

2014-04-14

Start date

2014-04-30

Completion date

Unknown

Last updated

2014-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Women

Brief 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.

Interventions

DRUGEncapsulated vortioxetine IR tablet, 20 mg

DRUGVortioxetine MR capsule 20 mg (pH 5.5)

DRUGVortioxetine MR capsule 20 mg (pH 6.0)

DRUGVortioxetine MR capsule 20 mg (pH 7.0)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Gastro-intestinal tolerability (nausea) measured with 11-point Numerical Rating Scale	Up to 24 hours post-dose in each treatment period
Gastro-intestinal tolerability (abdominal pain) measured with 11-point Numerical Rating Scale	Up to 24 hours post-dose in each treatment period
Gastro-intestinal tolerability (abdominal discomfort) measured with 11-point Numerical Rating Scale	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)	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)	Up to 72 hours postdose
Maximum observed concentration (Cmax) of vortioxetine	Up to 72 hours postdose
Nominal time corresponding to the occurrence of Cmax (tmax)	Up to 72 hours postdose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026