Bioequivalence Study to Compare Two Formulations of Deanxit®

February 28, 2024 updated by: H. Lundbeck A/S

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

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China
        • CN1036 Shijitan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A1 Fasted condition
Subjects in cohort A1 will be administered the Investigational Medicinal Product in a fasted state, 30 subjects per cohort
0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose
0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose
Other Names:
  • Deanxit®
Experimental: Cohort A2 Fed condition
Subjects in cohort A2 will be administered the Investigational Medicinal Product in a fed state, 30 subjects per cohort
0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose
0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose
Other Names:
  • Deanxit®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-72h: flupentixol
Time Frame: from zero to 72 hours post-dose
the area under the flupentixol plasma concentration-time curve
from zero to 72 hours post-dose
Cmax: flupentixol
Time Frame: from zero to 72 hours post-dose
maximum observed plasma concentration of flupentixol
from zero to 72 hours post-dose
AUC0-72h: melitracen
Time Frame: from zero to 72 hours post-dose
the area under the melitracen plasma concentration-time curve
from zero to 72 hours post-dose
Cmax: melitracen
Time Frame: from zero to 72 hours post-dose
maximum observed concentration of melitracen
from zero to 72 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2018

Primary Completion (Actual)

June 28, 2018

Study Completion (Actual)

June 28, 2018

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 21, 2018

Study Record Updates

Last Update Posted (Actual)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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