NCT02179931

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Men and Women

Interventions

Type	Name	Description
DRUG	Flupentixol/melitracen film-coated tablet
DRUG	Flupentixol/melitracen coated tablet (Deanxit®)

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-07-01
• First posted: 2014-07-02
• Last updated: 2014-09-04

Locations

1 site across 1 country: United Kingdom