Healthy Women Clinical Trial
Official 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
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | GB801 | London |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastro-intestinal tolerability (nausea) measured with 11-point Numerical Rating Scale | Up to 24 hours post-dose in each treatment period | Yes | |
Primary | Gastro-intestinal tolerability (abdominal pain) measured with 11-point Numerical Rating Scale | Up to 24 hours post-dose in each treatment period | Yes | |
Primary | Gastro-intestinal tolerability (abdominal discomfort) measured with 11-point Numerical Rating Scale | Up to 24 hours post-dose in each treatment period | Yes | |
Primary | 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 | Yes | |
Primary | Area under the vortioxetine plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h) | Up to 72 hours postdose | No | |
Primary | Maximum observed concentration (Cmax) of vortioxetine | Up to 72 hours postdose | No | |
Primary | Nominal time corresponding to the occurrence of Cmax (tmax) | Up to 72 hours postdose | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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