Bioequivalence Study in Healthy SubjectsPhase 1NCT06969963
Bioequivalence Assessment Between Two Perampanel Oral Suspension Formulations
A Phase 1 study testing Lepsiramp, 0.5 Mg/mL Oral Suspension and Fycompa, 0.5 Mg/mL Oral Suspension in people with Bioequivalence Study in Healthy Subjects, run by Aya Mohammed Abdel Magid Abdel Hamid at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study in Healthy Subjects
- What is being tested?
- Lepsiramp, 0.5 Mg/mL Oral Suspension and Fycompa, 0.5 Mg/mL Oral Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Mar 2024to 23 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
- Using an adequate contraception method during the study and for at least 30 days after the study (for potential subjects).
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Lepsiramp, 0.5 Mg/mL Oral Suspension, Fycompa, 0.5 Mg/mL Oral Suspension
- Keywords
- Perampanel, Bioequivalence, Oral suspension, Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lepsiramp, 0.5 Mg/mL Oral SuspensionDrug
Also called Perampanel 0.5mg/mL
Test product
Fycompa, 0.5 Mg/mL Oral SuspensionDrug
Also called perampanel 0.5mg/mL
Reference product
| Study group | Role | What they receive |
|---|---|---|
| Lepsiramp (perampanel 0.5 mg/mL) oral suspension | Active comparator | Test Product Receives: Drug: Lepsiramp, 0.5 Mg/mL Oral Suspension |
| Fycompa® (perampanel 0.5 mg/mL) oral suspension | Active comparator | Reference Product Receives: Drug: Fycompa, 0.5 Mg/mL Oral Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak plasma concentration
Measured: 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
Measured: From time zero up to 72 hours in each study period
Secondary outcomes (1)
Tmax
The time of the peak plasma concentration
Measured: From time zero up to 72 hours in each study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start7 Mar 2024
- Primary completion23 Jul 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bioequivalence Study in Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- single center, open label, randomized, single-dose, 2-sequence, 2-period, crossover, bioequivalence trial conducted under fasting conditions with healthy participants
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aya Mohammed Abdel Magid Abdel Hamid
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Research Center (ARC), Global Napi Pharmaceuticals for Global Advanced Pharmaceuticals
- Responsible party
- Sponsor-investigator, Aya Mohammed Abdel Magid Abdel Hamid, Cairo University
- Investigators
- Kamal A. Badr, Ph.D., Study director, Advanced Research Center (ARC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969963
- Sponsor's protocol ID
- BE0124LEP0.5-GAP/01
- Status last verified
- Aug 2025
- First submitted
- 29 Apr 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 41249688
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06969963
- Acronym / sponsor ID
- BE0124LEP0.5-GAP/01
- Conditions
- Bioequivalence Study in Healthy Subjects
- Keywords
- Perampanel, Bioequivalence, Oral suspension, Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aya Mohammed Abdel Magid Abdel HamidUniversity, hospital or other
- Collaborators
- Advanced Research Center (ARC), Global Napi Pharmaceuticals for Global Advanced Pharmaceuticals
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single center, open label, randomized, single-dose, 2-sequence, 2-period, crossover, bioequivalence trial conducted under fasting conditions with healthy participants
| Arm | Type | Receives |
|---|---|---|
| Lepsiramp (perampanel 0.5 mg/mL) oral suspension | Active comparator | Drug: Lepsiramp, 0.5 Mg/mL Oral SuspensionTest Product |
| Fycompa® (perampanel 0.5 mg/mL) oral suspension | Active comparator | Drug: Fycompa, 0.5 Mg/mL Oral SuspensionReference Product |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lepsiramp, 0.5 Mg/mL Oral SuspensionAlso: Perampanel 0.5mg/mLTest product | Drug | Lepsiramp (perampanel 0.5 mg/mL) oral suspension |
| Fycompa, 0.5 Mg/mL Oral SuspensionAlso: perampanel 0.5mg/mLReference product | Drug | Fycompa® (perampanel 0.5 mg/mL) oral suspension |
Primary outcome
Cmax
Time frame: From time zero up to 72 hours in each study period
Peak plasma concentration
AUC(0-72)
Time frame: From time zero up to 72 hours in each study period
The area under the plasma concentration-time curve up to 72 hours
1 secondary outcome
Tmax
Time frame: From time zero up to 72 hours in each study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Derived from this study: PubMed 41249688AbdelMagid 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamal A. Badr, Ph.D. study director
Advanced Research Center (ARC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lepsiramp, 0.5 Mg/mL Oral Suspension and Fycompa, 0.5 Mg/mL Oral Suspension in people with Bioequivalence Study in Healthy Subjects, run by Aya Mohammed Abdel Magid Abdel Hamid at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: From time zero up to 72 hours in each study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06969963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.