Bioequivalence Assessment Between Two Perampanel Oral Suspension Formulations
Status:
COMPLETED
Trial end date:
2024-07-23
Target enrollment:
Participant gender:
Summary
An open label, randomized, single-dose, two-sequences, two-periods, crossover study to assess the bioequivalence of perampanel in Lepsiramp 0.5mg/ml oral suspension (Test product) in comparison with Fycompa 0.5mg/ml oral suspension (Reference product) in healthy subjects under fasting conditions.
Phase:
PHASE1
Details
Lead Sponsor:
Aya Mohammed Abdel Magid Abdel Hamid
Collaborators:
Advanced Research Center (ARC) Global Napi Pharmaceuticals for Global Advanced Pharmaceuticals