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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