Skip to main content
OpenTrials
Completed

NCT Number: NCT02660840

Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bioequivalence Study in Healthy Subjects

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

RU801

Moscow, Russia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.5 mg Flupentixol film-coated tablet (test treatment)

Drug

single oral dose, fasted state, day 1 in period 1 or 2

1 mg Flupentixol film-coated tablet (test treatment)

Drug

single oral dose, fasted state, day 1 in period 1 or 2

5 mg Flupentixol film-coated tablet (test treatment)

Drug

single oral dose, fasted state, day 1 in period 1 or 2

0.5 mg Flupentixol coated tablet (reference treatment)

Drug

single oral dose, fasted state, day 1 in period 1 or 2

Other names: Fluanxol®

1 mg Flupentixol coated tablet (reference treatment)

Drug

single oral dose, fasted state, day 1 in period 1 or 2

Other names: Fluanxol®

5 mg Flupentixol coated tablet (reference treatment)

Drug

single oral dose, fasted state, day 1 in period 1 or 2

Other names: Fluanxol®

Primary outcomes

  1. The area under the plasma concentration-time curve

    Time frame: from 0 to 72 hours post-dose

  2. The maximum observed concentration (Cmax)

    Time frame: from 0 to 72 hours post-dose

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
First posted
Jan 21, 2016
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.