Therapeutic Equivalency Clinical Trial
Official title:
Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administration
Methodology:
The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female
volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or
Sabril, as single oral administration in 2 different study periods depending on the
randomization, with a 7-days wash out period between administrations
Objectives:
Primary objective:
Evaluate bioequivalence between a new paediatric formulation of vigabatrin (VGB-ST) and
Sabril granules for oral administration.
Secondary objective:
- Define pharmacokinetic parameters of the new paediatric formulation soluble tablets of
vigabatrin (VGB-ST)
- Assess the safety of the new formulation of soluble tablets VGB-ST versus Sabril
;
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