NCT03472651

Bioequivalence Study to Compare Two Formulations of Deanxit®

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to establish bioequivalence of flupentixol/meltracen, between a new film-coated tablet formulation and the marketed coated tablet formulation (Deanxit®), administered single dose in fasted and fed condition

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	test treatment: flupentixol/melitracen	0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose
DRUG	reference treatment: flupentixol/melitracen	0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose

Timeline

• Start date: 2018-05-07
• Primary completion: 2018-06-28
• Completion: 2018-06-28
• First posted: 2018-03-21
• Last updated: 2024-02-29

Locations

1 site across 1 country: China