Bioequivalence
Research type
Research Study
Full title
Interventional, single dose, open-label, randomised, crossover, bioequivalence study in healthy men and women to compare two pharmaceutical formulations of flupentixol/melitracen (Deanxit®)
IRAS ID
156027
Contact name
Jim Bush
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2014-000431-17
Research summary
The Study Drug (Deanxit®) has been marketed in several countries since 1971 to help treat people with anxiety, depression and asthenia (generalised weakness).
The Study Drug is currently manufactured as a coated tablet containing 0.5 mg flupentixol and 10 mg melitracen. A new film-coated tablet with the same contents (0.5 mg flupentixol and 10 mg melitracen) has been developed to make use of technological advances in coating tablets in for medicine.
The main purpose of the study is to prove that the new film coated tablet (test treatment) produces similar drug levels and therefore anticipated to be as effective as the marketed coated tablet formulation of Deanxit (reference treatment).
Up to 30 healthy volunteers are planned to take part in this single site research study.
During this study, subjects will participate in 2 treatment periods during which they will receive a single dose of two different pharmaceutical formulations (one film-coated and one coated tablet formulations) in each of the treatment periods.Subject participation is expected to last up to 8 weeks from the time of screening till the last post-study visit.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/0281
Date of REC Opinion
30 May 2014
REC opinion
Further Information Favourable Opinion