Bioequivalence Assessment Between Two Perampanel Oral Suspension Formulations

NCT06969963 | Completed Phase 1 DMC

• 1 other identifier: BE0124LEP0.5-GAP/01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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® 0.5mg/ml oral suspension (Reference product) in healthy subjects under fasting conditions.

Conditions

Bioequivalence Study in Healthy Subjects

Keywords

Perampanel; Bioequivalence; Oral suspension; Epilepsy

Outcome Measures

Primary Outcomes (2)

• Cmax

  Peak plasma concentration

  From time zero up to 72 hours in each study period

• AUC(0-72)

  The area under the plasma concentration-time curve up to 72 hours

  From time zero up to 72 hours in each study period

Secondary Outcomes (1)

• Tmax

  From time zero up to 72 hours in each study period

Study Arms (2)

Lepsiramp (perampanel 0.5 mg/mL) oral suspension

ACTIVE COMPARATOR

Test Product

Drug: Lepsiramp, 0.5 Mg/mL Oral Suspension

Fycompa® (perampanel 0.5 mg/mL) oral suspension

ACTIVE COMPARATOR

Reference Product

Drug: Fycompa, 0.5 Mg/mL Oral Suspension

Interventions

Lepsiramp, 0.5 Mg/mL Oral Suspension DRUG

Test product

Also known as: Perampanel 0.5mg/mL

Lepsiramp (perampanel 0.5 mg/mL) oral suspension

Fycompa, 0.5 Mg/mL Oral Suspension DRUG

Reference product

Also known as: perampanel 0.5mg/mL

Fycompa® (perampanel 0.5 mg/mL) oral suspension

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects aged between 18 and 55 years.
• Non-smokers or mild smokers with a maximum limit of 5 cigarettes/day.
• Normal physical examinations at screening visit.
• Having BMI ranged between 18.5-30 kg/m2.
• Ability to communicate adequately with the clinical staff.
• Ability and agreement to comply with the study requirements.
• Normal BP and HR measured under stabilized conditions.
• The Blood pressure is considered normal if the SBP falls within 100 to 140 mmHg, and the DBP within 60 to 90 mmHg.
• The heart rate normal range is from 60 to 100 bpm.
• Respiratory rate normal range is from 12 to 16 breaths per minute.
• Temperature normal range is from 36.5ºC to 37.5ºC.
• Normal laboratory results within normal range or with clinically non-significant deviation including: Complete Blood Count, Clinical Chemistry: Random blood sugar, blood urea, creatinine, sodium, potassium, total bilirubin, alanine amino transferase (ALT/GPT), aspartate amino transferase (AST/GOT), alkaline phosphatase, total protein in serum, Lipid profile, urinalysis.
• Negative Virology tests: HIV (HIV Ab), hepatitis B (HBsAg), hepatitis C (HCV IgG).
• Negative results for abused drug analysis in urine (Amphetamine (AMP), Barbiturate (BAR), Benzodiazepine (BZO), Cannabinoid (THC), Cocaine, Opiates (Morphine (MOP), Tramadol (TRA)).
• Understanding of the study and agreeing to give a written informed consent.

You may not qualify if:

• Subjects who have atopic constitution, asthma or known allergy for the API under investigation and/or any other ingredients of the investigational product.
• Presence of clinical relevance of cardiovascular, neurological, musculoskeletal, hematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease.
• Symptomatic or asymptomatic orthostatic hypotension at screening defined by a decrease of SBP more than 20 mmHg or DBP more than 10 mmHg occurs between sitting/supine to standing position. The subject will be excluded (if the drug under investigation has antihypertensive properties or documented to have orthostatic hypotension as a side effect).
• Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or herniotomy.
• Subjects who have given more than 400 mL blood within the last two months before the first drug administration and subjects who have participated in any drug research within the last two months before the first day of drug administration.
• Subjects who used any prescribed systemic medication (including OTC medication) within 2 weeks (or six elimination half-lives of this medication, whichever is longer) before the initiation of the study (except for single doses of analgesics which have no drug interaction with study product).
• Use of any vitamins or herbal products within 3 days prior to the initial dose of the study medication.
• Subjects who have any chronic disease which might interfere with the absorption, distribution, metabolism or excretion of the drug.
• Subjects who consumed grapefruit or grapefruit juice during 48 hr prior to drug administration, during the study.
• History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or positive alcohol test.
• History of difficulty of swallowing.
• Intake of enzyme-inducing, organ toxic, long half-life drugs within 4 weeks before start of the study
• Subjects who follow a special diet due to any reason, e.g., vegetarian.
• Has a recent acute infection.
• Pregnant females or female subjects who practice lactation or unprotected females with pregnancy potential

Sponsors & Collaborators

• Aya Mohammed Abdel Magid Abdel Hamid: lead
• Advanced Research Center (ARC): collaborator
• Global Napi Pharmaceuticals for Global Advanced Pharmaceuticals: collaborator

Study Sites (1)

Advanced Research Center (ARC)

Cairo, Cairo Governorate, Egypt

Location

Related Publications (1)

• AbdelMagid AM, Badr KA, Rezk MR. Bioequivalence of Two Perampanel Oral Suspension Formulations in Healthy Subjects: A Randomized Crossover Study. Drugs R D. 2025 Dec;25(4):343-351. doi: 10.1007/s40268-025-00526-5. Epub 2025 Nov 18.

  PMID: 41249688 DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

Suspensions; perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Kamal A. Badr, Ph.D.

  Advanced Research Center (ARC)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Model Details: single center, open label, randomized, single-dose, 2-sequence, 2-period, crossover, bioequivalence trial conducted under fasting conditions with healthy participants

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 14, 2025
• Study Start: March 7, 2024
• Primary Completion: July 23, 2024
• Study Completion: July 23, 2024
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)