U.S., May 15 -- ClinicalTrials.gov registry received information related to the study (NCT06969963) titled 'Bioequivalence Assessment Between Two Perampanel Oral Suspension Formulations' on April 29.
Brief 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(R) 0.5mg/ml oral suspension (Reference product) in healthy subjects under fasting conditions.
Study Start Date: March 07, 2024
Study Type: INTERVENTIONAL
Condition:
Bioequivalence Study in Healthy Subjects
Intervention:
DRUG: Lepsiramp, 0.5 Mg/mL Oral Suspension
Test product
DRUG: Fycompa, 0.5 Mg/mL Oral Suspension
R...