NCT02179931

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2014

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
Last Updated

September 4, 2014

Status Verified

September 1, 2014

Enrollment Period

1 month

First QC Date

June 30, 2014

Last Update Submit

September 3, 2014

Conditions

Healthy Men and Women

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Flupentixol/melitracen film-coated tablet

EXPERIMENTAL

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

Drug: Flupentixol/melitracen film-coated tablet

Flupentixol/melitracen coated tablet (Deanxit®)

OTHER

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

Drug: Flupentixol/melitracen coated tablet (Deanxit®)

Interventions

Flupentixol/melitracen film-coated tabletDRUG
Flupentixol/melitracen film-coated tablet
Flupentixol/melitracen coated tablet (Deanxit®)DRUG
Flupentixol/melitracen coated tablet (Deanxit®)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

Flupenthixolflupentixol, melitracen drug combination

Intervention Hierarchy (Ancestors)

ThioxanthenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsXanthenesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 2, 2014

Study Start

June 1, 2014

Primary Completion

July 1, 2014

Last Updated

September 4, 2014

Record last verified: 2014-09

Locations

GB(1)