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Completed

NCT Number: NCT02179931

Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)

To establish bioequivalence of flupentixol/melitracen between a new film-coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen and the marketed coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen (Deanxit®), administered as single doses.

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Key information

Conditions

Healthy Men and Women

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Leeds, LS2 9LH, United Kingdom

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 <30 kg/m2.
  • Women will be non-pregnant and non-lactating.

Other protocol-defined inclusion and exclusion criteria may apply.

Treatment and study plan

Flupentixol/melitracen film-coated tablet

Drug

Flupentixol/melitracen coated tablet (Deanxit®)

Drug

Primary outcomes

  1. Area under the flupentixol plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)

    Time frame: Up to 72 hours post dose

  2. Maximum observed concentration (Cmax) of flupentixol

    Time frame: Up to 312 hours post dose

  3. Area under the melitracen plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h)

    Time frame: Up to 72 hours post dose

  4. Maximum observed concentration (Cmax) of melitracen

    Time frame: Up to 312 hours post dose

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
First posted
Jul 2, 2014
Registry last updated
Sep 4, 2014

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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