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

Phase 1

Completed

• Conditions: Healthy Men and Women
• Interventions: Drug: Flupentixol/melitracen coated tablet (Deanxit®); Drug: Flupentixol/melitracen film-coated tablet

• Registration Number: NCT02179931
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-06-30
• Primary Completion: 2014-07
• Study First Posted: 2014-07-02
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-03
• Last Update Posted: 2014-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Flupentixol/melitracen coated tablet (Deanxit®)	Flupentixol/melitracen coated tablet (Deanxit®)	reference treatment - 0.5 mg/10 mg, oral as a single dose
Flupentixol/melitracen film-coated tablet	Flupentixol/melitracen film-coated tablet	test treatment - 0.5 mg/10 mg; oral as a single dose

Primary Outcome Measures

Name	Time	Method
Area under the flupentixol plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)	Up to 72 hours post dose
Maximum observed concentration (Cmax) of flupentixol	Up to 312 hours post dose
Area under the melitracen plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)	Up to 72 hours post dose
Maximum observed concentration (Cmax) of melitracen	Up to 312 hours post dose

Trial Locations

Locations (1)

Covance Clinical Research Unit; 🇬🇧 Leeds, United Kingdom