Bioequivalence Study to Compare Two Formulations of Deanxit®
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT03472651
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method AUC0-72h: flupentixol from zero to 72 hours post-dose the area under the flupentixol plasma concentration-time curve
AUC0-72h: melitracen from zero to 72 hours post-dose the area under the melitracen plasma concentration-time curve
Cmax: melitracen from zero to 72 hours post-dose maximum observed concentration of melitracen
Cmax: flupentixol from zero to 72 hours post-dose maximum observed plasma concentration of flupentixol
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CN1036 Shijitan Hospital
🇨🇳Beijing, China