Trial reportDrugs in R&D2025
Bioequivalence of Two Perampanel Oral Suspension Formulations in Healthy Subjects: A Randomized Crossover Study.
Trial report in Drugs in R&D, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06969963 (Single-dose, Randomized, Two-period, Two-sequence Crossover Study to Evaluate the Bioequivalence of Lepsiramp 0.5mg/ml Oral Suspension), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Single-dose, Randomized, Two-period, Two-sequence Crossover Study to Evaluate the Bioequivalence of Lepsiramp 0.5mg/ml Oral Suspension (Test) and Fycompa® 0.5mg/ml Oral Suspension (Reference) Under Fasting Conditions
Who cites it
2 citing papers in PubMed.
- Bioequivalence evaluation of two cariprazine hard capsule formulations.Naunyn-Schmiedeberg's archives of pharmacology · 2026Trial
- A Novel Ultra-Performance Liquid Chromatography-Electrospray Ionisation-Tandem Mass Spectrometry Method for Quantification of Imeglimin in Human Plasma: Application to a Bioequivalence Study.Analytical science advances · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivePerampanel 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.
methodsThis 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
resultsThe 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
conclusionsThe 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 registrationThe ClinicalTrials.gov registration number is NCT06969963, retrospectively registered on 13 May, 2025.
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