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Bioequivalence Assessment Between Two Perampanel Oral Suspension Formulations

NCT06969963 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-08-20

No results posted yet for this study

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.

Conditions

  • Bioequivalence Study in Healthy Subjects

Interventions

DRUG

Lepsiramp, 0.5 Mg/mL Oral Suspension

Test product

DRUG

Fycompa, 0.5 Mg/mL Oral Suspension

Reference product

Sponsors & Collaborators

  • Advanced Research Center (ARC)

    collaborator UNKNOWN

  • Global Napi Pharmaceuticals for Global Advanced Pharmaceuticals

    collaborator UNKNOWN

  • Aya Mohammed Abdel Magid Abdel Hamid

    lead OTHER

Principal Investigators

  • Kamal A. Badr, Ph.D. · Advanced Research Center (ARC)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2024-07-23
Completion
2024-07-23

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06969963 on ClinicalTrials.gov