Bioequivalence Study to Compare Two Formulations of Deanxit®

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 28, 2018

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Cohort A1 Fasted condition
    • Subjects in cohort A1 will be administered the Investigational Medicinal Product in a fasted state, 30 subjects per cohort
  • Experimental: Cohort A2 Fed condition
    • Subjects in cohort A2 will be administered the Investigational Medicinal Product in a fed state, 30 subjects per cohort

Clinical Trial Outcome Measures

Primary Measures

  • AUC0-72h: flupentixol
    • Time Frame: from zero to 72 hours post-dose
    • the area under the flupentixol plasma concentration-time curve
  • Cmax: flupentixol
    • Time Frame: from zero to 72 hours post-dose
    • maximum observed plasma concentration of flupentixol
  • AUC0-72h: melitracen
    • Time Frame: from zero to 72 hours post-dose
    • the area under the melitracen plasma concentration-time curve
  • Cmax: melitracen
    • Time Frame: from zero to 72 hours post-dose
    • maximum observed concentration of melitracen

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy men and women ≥18 and ≤55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 28 kg/m2. – Women must be non-pregnant and non-lactating

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • H. Lundbeck A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Email contact via H. Lundbeck A/S, Study Director, LundbeckClinicalTrials@Lundbeck.com

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