EpilepsyPhase 1NCT06450223

Bioequivalence Study of Perampanel Tablets 12 mg

A Phase 1 study testing Perampanel 12 MG and Fycompa 12 mg film-coated tablets in people with Epilepsy, run by Humanis Saglık Anonim Sirketi at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single dose bioequivalence study of Perampanel Tablets 12 mg of Humanis Sağlık A.ġ., Turkey and Fycompa 12 mg film-coated tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany in normal, healthy… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Epilepsy
What is being tested?: Perampanel 12 MG and Fycompa 12 mg film-coated tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteIndia
Study dates: 14 Sep 2023to 5 Dec 2023
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study; Willing to be available for the entire study period and to comply protocol requirements;
Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age;
Body mass index in the range of 18.50 - 30.00 kg/m2 (both inclusive);
Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs measurements and physical examination at the time of screening as well as check-in of each study period;
Normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis;
Normal or clinically non-significant 12-lead ECG recording;

Show all 12Show fewer

Non-smokers or subjects who have no history of smoking for the last one year prior to check-in;
Subjects who are willing to abstain from chewing any tobacco containing products at least 72.00 hours prior to check-in until last sample collection in each study period;
Non Alcoholic; Willing to abstain from xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks), at least 48.00 hours prior to check-in until last sample collection in each study period;
Willing to abstain from grapefruit or its juice at least 72.00 hours prior to check-in until last sample collection in each study period;
For female subjects: Negative urine pregnancy test during screening and negative serum β-hCG test at the time of check-in of each study period;
Female subjects with child bearing potential or those within their first two years of onset of menopausal syndrome willing to either abstain from sexual intercourse, or should use of acceptable birth control methods for at least 15 days before 1st check-in till 15 days post last-dose / entire study period. [Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed)].

Who cannot join

Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of blood forming organs;
Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction;
Any major illness or hospitalized within 90 days prior to the first check-in;
Requiring medication for any ailment having enzyme-modifying activity within one month prior to first check-in and throughout the study;
Use of any depot injection or an implant of any drug within 3 months prior to first check-in and throughout the study;
History or presence of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.The reason for subject discontinuation will be documented in the subject's case report form (CRF).

Trial locations and contacts

1 site in 1 country.

India1 site

Raptim Research Pvt. Ltd.,
Navi Mumbai

Other trials in India

About this study

Official title: An Open-label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Two Way Cross-over, Single Dose Bioequivalence Study of Perampanel Tablets 12 mg of Humanis Sağlık A.Ş., Turkey and Fycompa 12 mg Film-coated Tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

Conditions: Epilepsy
Being tested: Perampanel 12 MG, Fycompa 12 mg film-coated tablets
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Perampanel 12 MGDrug
1 tablet of Perampanel Tablets 12 mg
Fycompa 12 mg film-coated tabletsDrug
1 tablet of Perampanel Tablets 12 mg

Study groups in NCT06450223
Study group	Role	What they receive
Perampanel Tablets	Experimental	Perampanel Tablets 12mg Receives: Drug: Perampanel 12 MG
Fycompa film-coated tablets	Active comparator	Fycompa 12mg film-coated tablets (Perampanel12 mg) Receives: Drug: Fycompa 12 mg film-coated tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum concentration obtained (Cmax)
two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data Cmax
Measured: 23 hours
AUC from time 0 to last collection time 72 (AUC0-72)
two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data AUC0-72
Measured: 23 hours

Secondary outcomes (1)

Time of the maximum measured plasma concentration (Tmax)
Description Statistics
Measured: 23 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 20235 Dec 2023

First posted10 Jun 2024
Study start14 Sep 2023
Primary completion20 Sep 2023
Study completion5 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for EpilepsyStudies 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
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06450223
Sponsor's protocol ID: PR/BE/23/229
Status last verified: Jun 2024
First submitted: 4 Jun 2024
Last updated: 12 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
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RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Two Way Cross-over, Single Dose Bioequivalence Study of Perampanel Tablets 12 mg of Humanis Sağlık A.Ş., Turkey and Fycompa 12 mg Film-coated Tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
ClinicalTrials.gov ID: NCT06450223
Acronym / sponsor ID: PR/BE/23/229
Conditions: Epilepsy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
Study start: 14 Sep 2023 (actual)
Primary completion: 20 Sep 2023 (actual)
Study completion: 5 Dec 2023 (actual)
First posted: 10 Jun 2024 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Perampanel Tablets	Experimental	Drug: Perampanel 12 MGPerampanel Tablets 12mg
Fycompa film-coated tablets	Active comparator	Drug: Fycompa 12 mg film-coated tabletsFycompa 12mg film-coated tablets (Perampanel12 mg)

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study; Willing to be available for the entire study period and to comply protocol requirements;
Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age;
Body mass index in the range of 18.50 - 30.00 kg/m2 (both inclusive);
Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs measurements and physical examination at the time of screening as well as check-in of each study period;
Normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis;

Key exclusion criteria (6 listed)

Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of blood forming organs;
Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction;
Any major illness or hospitalized within 90 days prior to the first check-in;
Requiring medication for any ailment having enzyme-modifying activity within one month prior to first check-in and throughout the study;
Use of any depot injection or an implant of any drug within 3 months prior to first check-in and throughout the study;

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
Perampanel 12 MG1 tablet of Perampanel Tablets 12 mg	Drug	Perampanel Tablets
Fycompa 12 mg film-coated tablets1 tablet of Perampanel Tablets 12 mg	Drug	Fycompa film-coated tablets

Primary outcome

Maximum concentration obtained (Cmax)
Time frame: 23 hours
two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data Cmax
AUC from time 0 to last collection time 72 (AUC0-72)
Time frame: 23 hours
two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data AUC0-72

1 secondary outcome

Time of the maximum measured plasma concentration (Tmax)
Time frame: 23 hours

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 12 Jun 2024.
Individual participant dataSharing planned: No

Related trials for Epilepsy

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Perampanel 12 MG and Fycompa 12 mg film-coated tablets in people with Epilepsy, run by Humanis Saglık Anonim Sirketi at 1 site in India.

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 12 inclusion and 6 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 12 Jun 2024. 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 India. 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?

Maximum concentration obtained (Cmax) (time frame: 23 hours). 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 NCT06450223.

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 12 Jun 2024.