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Clinical Trial Summary

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


Clinical Trial Description

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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04468282
Study type Interventional
Source Orphelia Pharma
Contact
Status Completed
Phase Phase 1
Start date April 4, 2017
Completion date August 8, 2017

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