Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)
Phase 1
Completed
- Conditions
- Healthy Men and Women
- Interventions
- Drug: Flupentixol/melitracen coated tablet (Deanxit®)Drug: Flupentixol/melitracen film-coated tablet
- Registration Number
- NCT02179931
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Flupentixol/melitracen coated tablet (Deanxit®) Flupentixol/melitracen coated tablet (Deanxit®) reference treatment - 0.5 mg/10 mg, oral as a single dose Flupentixol/melitracen film-coated tablet Flupentixol/melitracen film-coated tablet test treatment - 0.5 mg/10 mg; oral as a single dose
- Primary Outcome Measures
Name Time Method Area under the flupentixol plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h) Up to 72 hours post dose Maximum observed concentration (Cmax) of flupentixol Up to 312 hours post dose Area under the melitracen plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h) Up to 72 hours post dose Maximum observed concentration (Cmax) of melitracen Up to 312 hours post dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Covance Clinical Research Unit
🇬🇧Leeds, United Kingdom