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

NCT04468282 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-07-13

No results posted yet for this study

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

Conditions

  • Therapeutic Equivalency

Interventions

DRUG

VGB-ST

Single oral administration of 500 mg VGB-ST

Sponsors & Collaborators

  • Orphelia Pharma

    lead INDUSTRY

Principal Investigators

  • PharmD PharmD, PhD · Orphelia Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-04
Primary Completion
2017-08-08
Completion
2017-08-08

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04468282 on ClinicalTrials.gov