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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy Men and Women

Treatments: Drug: Flupentixol/melitracen coated tablet (Deanxit®); Drug: Flupentixol/melitracen film-coated tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02179931

2014-000431-17 (EudraCT Number)

15972A

Details and patient eligibility

About

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.

Enrollment: 30 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 <30 kg/m2.
• Women will be non-pregnant and non-lactating.

Other protocol-defined inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Flupentixol/melitracen film-coated tablet

Experimental group

Description:

test treatment - 0.5 mg/10 mg; oral as a single dose

Treatment:

Drug: Flupentixol/melitracen film-coated tablet

Flupentixol/melitracen coated tablet (Deanxit®)

Other group

Description:

reference treatment - 0.5 mg/10 mg, oral as a single dose

Treatment:

Drug: Flupentixol/melitracen coated tablet (Deanxit®)