Overview

Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administration

Status:
Completed

Trial end date:
2017-08-08

Target enrollment:

Participant gender:

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

Phase:

Phase 1

Details

Lead Sponsor:

Orphelia Pharma

Treatments:

Vigabatrin