Bioequivalence Study to Compare Two Formulations of Deanxit®

H. Lundbeck A/S60 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

test treatment: flupentixol/melitracenDRUG

0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose

reference treatment: flupentixol/melitracenDRUG

0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose

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 ≤ 28 kg/m2. * Women must be non-pregnant and non-lactating

Locations (1)

CN1036 Shijitan Hospital

Beijing, China

Outcomes

Primary Outcomes

AUC0-72h: flupentixol

the area under the flupentixol plasma concentration-time curve

Time frame: from zero to 72 hours post-dose

Cmax: flupentixol

maximum observed plasma concentration of flupentixol

Time frame: from zero to 72 hours post-dose

AUC0-72h: melitracen

the area under the melitracen plasma concentration-time curve

Time frame: from zero to 72 hours post-dose

Cmax: melitracen

maximum observed concentration of melitracen

Time frame: from zero to 72 hours post-dose

Data from ClinicalTrials.gov

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