Bioequivalence Study to Compare Two Formulations of Deanxit®

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: test treatment: flupentixol/melitracen; Drug: reference treatment: flupentixol/melitracen

Study type: Interventional

Funder types: Industry

Identifiers

NCT03472651

17686A

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Cohort A1 Fasted condition

Experimental group

Description:

Subjects in cohort A1 will be administered the Investigational Medicinal Product in a fasted state, 30 subjects per cohort

Treatment:

Drug: test treatment: flupentixol/melitracen

Drug: reference treatment: flupentixol/melitracen

Cohort A2 Fed condition

Experimental group

Description:

Subjects in cohort A2 will be administered the Investigational Medicinal Product in a fed state, 30 subjects per cohort

Treatment:

Drug: test treatment: flupentixol/melitracen

Drug: reference treatment: flupentixol/melitracen