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Bioequivalence of Vigabatrin Soluble Tablets (Kigabeq) vs Sabril Granules
NCT04468282Phase 1Completed
- Sponsor
- ORPHELIA Pharma
- Start
- Apr 2017
- Primary completion
- Aug 2017
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, open-label trial of vigabatrin in infantile epileptic spasms syndrome (IESS) and focal epilepsy (2 arms), sponsored by ORPHELIA Pharma. Primary endpoint: Primary pharmacokinetic parameters (Bioequivalence) at Day 2. Started Apr 2017; status: completed.
02
Drugs
vigabatrin
03
Conditions
infantile epileptic spasms syndrome (IESS)focal epilepsy
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