Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations

July 25, 2016 updated by: H. Lundbeck A/S

Interventional, Open-label, Randomised, Crossover, Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations - Film Coated Tablet (Test Treatment) - 0.5 mg, 1 mg and 5 mg (H. Lundbeck A/S, Denmark) and Coated Tablet (Fluanxol®) - 0.5 mg, 1 mg and 5 mg (H. Lundbeck A/S, Denmark) in Healthy Volunteers

To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and 5 mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg flupentixol, administered as single doses

Study Overview

Detailed Description

All subjects will be confined to the clinic from Day -1 (Baseline) until Day 6 (120 hours post-dose) for each dosing period. First and second dosing will be separated by a washout period of at least 21 days

Study Type

Interventional

Enrollment (Actual)

84

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

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • body mass index (BMI) of ≥18.5 and ≤30 kg/m2
  • The subject is, in the opinion of the investigator, generally healthy based on medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

  • The subject is pregnant or breastfeeding.
  • The subject has taken any investigational medicinal products 3 months prior to the first dose
  • The subject has tested positive at the Screening Visit or at the Baseline Visit for drugs of abuse (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates, benzodiazepines, and cannabinoids).

Other protocol defined inclusion and exclusion criteria may apply

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: 0.5 mg Test, then 0.5 mg reference
14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first test, then reference)
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
Other Names:
  • Fluanxol®
Experimental: 0.5 mg reference, then 0.5 mg Test
14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first reference, then test)
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
Other Names:
  • Fluanxol®
Experimental: 1 mg Test, then 1 mg reference
14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first test, then reference)
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
Other Names:
  • Fluanxol®
Experimental: 1 mg reference, then 1 mg Test
14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first reference, then test)
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
Other Names:
  • Fluanxol®
Experimental: 5 mg Test, then 5 mg reference
14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first test, then reference)
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
Other Names:
  • Fluanxol®
Experimental: 5 mg reference, then 5 mg Test
14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first reference, then test)
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
Other Names:
  • Fluanxol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The area under the plasma concentration-time curve
Time Frame: from 0 to 72 hours post-dose
from 0 to 72 hours post-dose
The maximum observed concentration (Cmax)
Time Frame: from 0 to 72 hours post-dose
from 0 to 72 hours post-dose

Collaborators and Investigators

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

Sponsor

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

January 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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