Healthy
Conditions
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
Interventions
DRUGtest treatment: flupentixol/melitracen
0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose
DRUGreference treatment: flupentixol/melitracen
0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax: melitracen | from zero to 72 hours post-dose | maximum observed concentration of melitracen |
| AUC0-72h: flupentixol | from zero to 72 hours post-dose | the area under the flupentixol plasma concentration-time curve |
| Cmax: flupentixol | from zero to 72 hours post-dose | maximum observed plasma concentration of flupentixol |
| AUC0-72h: melitracen | from zero to 72 hours post-dose | the area under the melitracen plasma concentration-time curve |
Countries
China
Outcome results
None listed