NCT06969963

Bioequivalence Assessment Between Two Perampanel Oral Suspension Formulations

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Aya Mohammed Abdel Magid Abdel Hamid · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This was a single-dose, open-label, randomized, two-sequence, two-period crossover bioequivalence study conducted under fasting conditions at Advanced Research Center (ARC), Cairo, Egypt in 2024. The study compared the bioequivalence of Lepsiramp 0.5 mg/mL oral suspension (Test) with Fycompa® 0.5 mg/mL oral suspension (Reference), both formulations containing perampanel. Study Design Participants were randomized in a 1:1 ratio to receive the test or reference product across two study periods, separated by a 6-week washout. Each subject received a single 24 mL oral dose (equivalent to 12 mg perampanel) under fasting conditions. A standardized diet was provided during each period, and fluid intake was controlled pre- and post-dosing to maintain consistency. Blood Sampling Details In each period, 22 blood samples (5 mL each) were collected to characterize the plasma concentration-time profile. A forearm vein cannula was used for samples up to 24 hours; later samples were collected via venipuncture. Samples were centrifuged at 3500 rpm for 5 minutes at 4°C. Plasma was separated and stored at -80°C pending analysis. Pharmacokinetic and Bioanalytical Methods Plasma perampanel concentrations were quantified using a validated LC-MS/MS method with a calibration range of 3-400 ng/mL. The primary PK parameters included Cmax and AUC₀-₇₂, while secondary parameters were Tmax, AUC₀-inf, t½, and ke. PK analysis was conducted using Phoenix WinNonlin (v8.3.4), with calculations based on actual sampling times. Bioequivalence Evaluation Bioequivalence was determined if the 90% confidence intervals (CIs) for the geometric mean ratios (GMRs) of Cmax and AUC₀-₇₂ fell within the 80-125% range. ANOVA was applied to log-transformed data for Cmax and AUC, and Wilcoxon signed-rank test was used for Tmax comparisons. Safety Evaluation Subjects were monitored for adverse events throughout the study. Vital signs were assessed at multiple time points (pre-dose, and 2, 6, 12, and 72 hours post-dose). Complete blood counts were performed at the study's end. Statistical Analysis Sample size was calculated using R (v4.2.1), assuming a 19.35% intra-subject variability for Cmax, with 80% power, 5% significance level, and adjustment for expected dropouts. The Two One-Sided Tests (TOST) procedure was applied to log-transformed PK parameters to assess bioequivalence.

Conditions

• Bioequivalence Study in Healthy Subjects

Interventions

Type	Name	Description
DRUG	Lepsiramp, 0.5 Mg/mL Oral Suspension	Test product
DRUG	Fycompa, 0.5 Mg/mL Oral Suspension	Reference product

Timeline

• Start date: 2024-03-07
• Primary completion: 2024-07-23
• Completion: 2024-07-23
• First posted: 2025-05-14
• Last updated: 2025-08-20

Locations

1 site across 1 country: Egypt