NCT04468282

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Orphelia Pharma · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed 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

Conditions

• Therapeutic Equivalency

Interventions

Type	Name	Description
DRUG	VGB-ST	Single oral administration of 500 mg VGB-ST

Timeline

• Start date: 2017-04-04
• Primary completion: 2017-08-08
• Completion: 2017-08-08
• First posted: 2020-07-13
• Last updated: 2020-07-13

Locations

1 site across 1 country: France