Drugs in R&D · 2025
Bioequivalence of Two Perampanel Oral Suspension Formulations in Healthy Subjects: A Randomized Crossover Study.
Клиническое исследование I фазыСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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AbdelMagid Aya M, Badr Kamal A, Rezk Mamdouh R
Аннотация
BACKGROUND AND OBJECTIVE: Perampanel has been approved for the adjunctive treatment of partial-onset seizures and primary generalized tonic-clonic seizures. The oral suspension formulation benefits patients who have difficulty swallowing tablets. The unavailability of an affordable generic perampanel oral suspension formulation increased the need for a cheaper bioequivalent alternative to the marketed reference product. The study aimed to assess the bioequivalence of two formulations of perampanel oral suspension (0.5 mg/mL) administered under fasting conditions focusing on providing a cost-effective and accessible alternative to current formulations.
METHODS: This was an open-label, two-period, two-sequence, crossover, bioequivalence study conducted under fasting conditions. Healthy subjects were randomized to receive single doses of perampanel oral suspension (12 mg), Lepsiramp and Fycompa® separated by a 6-week washout period. The maximum concentration and area under the concentration-time curve up to 72 h were the primary pharmacokinetic parameters used to assess bioequivalence.
RESULTS: The geometric mean ratio of test to reference formulations and 90% confidence interval were 109.55 (99.49-120.64) for maximum concentration and 98.15 (90.68-106.23) for the area under the concentration-time curve up to 72 h, which were within the 80-125% bioequivalence range. The adverse events were mild headache and dizziness.
CONCLUSIONS: The two oral suspension formulations were bioequivalent, safe, and well tolerated. This provides a beneficial affordable alternative for patients requiring non-tablet oral formulations.
CLINICAL TRIAL REGISTRATION: The ClinicalTrials.gov registration number is NCT06969963, retrospectively registered on 13 May, 2025.
METHODS: This was an open-label, two-period, two-sequence, crossover, bioequivalence study conducted under fasting conditions. Healthy subjects were randomized to receive single doses of perampanel oral suspension (12 mg), Lepsiramp and Fycompa® separated by a 6-week washout period. The maximum concentration and area under the concentration-time curve up to 72 h were the primary pharmacokinetic parameters used to assess bioequivalence.
RESULTS: The geometric mean ratio of test to reference formulations and 90% confidence interval were 109.55 (99.49-120.64) for maximum concentration and 98.15 (90.68-106.23) for the area under the concentration-time curve up to 72 h, which were within the 80-125% bioequivalence range. The adverse events were mild headache and dizziness.
CONCLUSIONS: The two oral suspension formulations were bioequivalent, safe, and well tolerated. This provides a beneficial affordable alternative for patients requiring non-tablet oral formulations.
CLINICAL TRIAL REGISTRATION: The ClinicalTrials.gov registration number is NCT06969963, retrospectively registered on 13 May, 2025.