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

H. Lundbeck A/S30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Men and Women

Interventions

Flupentixol/melitracen film-coated tabletDRUG

Flupentixol/melitracen coated tablet (Deanxit®)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Covance Clinical Research Unit

Leeds, United Kingdom

Outcomes

Primary Outcomes

Area under the flupentixol plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)

Time frame: Up to 72 hours post dose

Maximum observed concentration (Cmax) of flupentixol

Time frame: Up to 312 hours post dose

Area under the melitracen plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)

Time frame: Up to 72 hours post dose

Maximum observed concentration (Cmax) of melitracen

Time frame: Up to 312 hours post dose

Data from ClinicalTrials.gov

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