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OpenTrials
Completed

NCT Number: NCT03472651

Bioequivalence Study to Compare Two Formulations of Deanxit®

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CN1036 Shijitan Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

test treatment: flupentixol/melitracen

Drug

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

reference treatment: flupentixol/melitracen

Drug

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

Other names: Deanxit®

Primary outcomes

  1. AUC0-72h: flupentixol

    Time frame: from zero to 72 hours post-dose

    the area under the flupentixol plasma concentration-time curve

  2. Cmax: flupentixol

    Time frame: from zero to 72 hours post-dose

    maximum observed plasma concentration of flupentixol

  3. AUC0-72h: melitracen

    Time frame: from zero to 72 hours post-dose

    the area under the melitracen plasma concentration-time curve

  4. Cmax: melitracen

    Time frame: from zero to 72 hours post-dose

    maximum observed concentration of melitracen

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2018
Registry last updated
Feb 29, 2024

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.

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