Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)

Healthy Men and Women Clinical Trial

Official title:

Interventional, Single Dose, Open-label, Randomised, Crossover, Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179931
• Other study ID #: 15972A
• Secondary ID: 2014-000431-17
• Status: Completed
• Phase: Phase 1
• First received: June 30, 2014
• Last updated: September 3, 2014
• Start date: June 2014

Study information

• Verified date: September 2014
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

To establish bioequivalence of flupentixol/melitracen between a new film-coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen and the marketed coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen (Deanxit®), administered as single doses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy men and women =18 and =55 years of age with a body mass index (BMI) of >18.5 and <30 kg/m2.

• Women will be non-pregnant and non-lactating.

Other protocol-defined inclusion and exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Men and Women

Intervention

Drug:
• Flupentixol/melitracen film-coated tablet

• Flupentixol/melitracen coated tablet (Deanxit®)

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the flupentixol plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)		Up to 72 hours post dose	No
Primary	Maximum observed concentration (Cmax) of flupentixol		Up to 312 hours post dose	No
Primary	Area under the melitracen plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)		Up to 72 hours post dose	No
Primary	Maximum observed concentration (Cmax) of melitracen		Up to 312 hours post dose	No