NCT03472651

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2018

Shorter than P25 for phase_1 healthy

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

First Submitted

Initial submission to the registry

March 14, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 7, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

March 14, 2018

Last Update Submit

February 28, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • AUC0-72h: flupentixol

    the area under the flupentixol plasma concentration-time curve

    from zero to 72 hours post-dose

  • Cmax: flupentixol

    maximum observed plasma concentration of flupentixol

    from zero to 72 hours post-dose

  • AUC0-72h: melitracen

    the area under the melitracen plasma concentration-time curve

    from zero to 72 hours post-dose

  • Cmax: melitracen

    maximum observed concentration of melitracen

    from zero to 72 hours post-dose

Study Arms (2)

Cohort A1 Fasted condition

EXPERIMENTAL

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

Drug: test treatment: flupentixol/melitracenDrug: reference treatment: flupentixol/melitracen

Cohort A2 Fed condition

EXPERIMENTAL

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

Drug: test treatment: flupentixol/melitracenDrug: reference treatment: flupentixol/melitracen

Interventions

test treatment: flupentixol/melitracenDRUG

0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose

Cohort A1 Fasted conditionCohort A2 Fed condition
reference treatment: flupentixol/melitracenDRUG

0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose

Also known as: Deanxit®
Cohort A1 Fasted conditionCohort A2 Fed condition

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 ≤ 28 kg/m2.
  • Women must be non-pregnant and non-lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CN1036 Shijitan Hospital

Beijing, China

Location

MeSH Terms

Interventions

flupentixol, melitracen drug combination

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

March 14, 2018

First Posted

March 21, 2018

Study Start

May 7, 2018

Primary Completion

June 28, 2018

Study Completion

June 28, 2018

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations

CN(1)