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

Interventional, Single Dose, Open-label, Randomised, Crossover, Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02179931

Enrollment

Registered

2014-07-02

Start date

2014-06-30

Completion date

Unknown

Last updated

2014-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Men and Women

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.

Interventions

DRUGFlupentixol/melitracen film-coated tablet

DRUGFlupentixol/melitracen coated tablet (Deanxit®)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026