EpilepsyPhase 1NCT06450236
Bioequivalence Study of Perampanel Tablets 10 mg
A Phase 1 study testing Perampanel 10 MG and Fycompa 10Mg Tablet in people with Epilepsy, run by Humanis Saglık Anonim Sirketi at 1 site in India.
Trial summary
An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single dose bioequivalence study of Perampanel Tablets 10 mg of Humanis Sağlık A.ġ., Turkey and Fycompa 10 mg film-coated tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Deutschland in normal… 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 10 MG and Fycompa 10Mg Tablet
- 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
- 22 Nov 2023to 6 Feb 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects fulfilling the following criteria were included in the study:
- 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;
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- 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;
- Non-smokers and 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 lastdose / 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
- Subjects with the following criteria were excluded from the study:
- 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;
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- History or presence of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- History of Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms(DRESS) and Stevens - Johnson Syndrome (SJS).
- Use of any prescribed medication (including herbal medicines and vitamin supplements) or OTC products within 30 days prior to first check-in and throughout the study;
- History or presence of significant gastric and/or duodenal ulceration;
- Difficulty in swallowing tablets or capsules;
- Use of any recreational drug or history of drug addiction;
- Participated in any clinical investigation requiring repeated blood sampling or have donated blood in past 90 days prior to first check-in;
- Positive urine alcohol and urine drug of abuse tests during check-in of each study period;
- Reactive test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies;
- Lactating or nursing female subjects;
- Female subjects using hormonal contraceptive (either oral/implants);
- History of allergy or hypersensitivity intolerance to perampanel or its formulation excipients which, in the opinion of a clinical investigator, would compromise the safety of the subject or the study;
- History of difficulty in accessibility of veins in arms.
Trial locations and contacts
1 site in 1 country.
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 10 mg of Humanis Sağlık A.Ş., Turkey and Fycompa 10 mg Film-coated Tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Deutschland in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single dose bioequivalence study of Perampanel Tablets 10 mg of Humanis Sağlık A.ġ., Turkey and Fycompa 10 mg film-coated tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Deutschland in normal, healthy, adult, human subjects under fasting condition.
- Conditions
- Epilepsy
- Being tested
- Perampanel 10 MG, Fycompa 10Mg Tablet
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perampanel 10 MGDrug
1 tablet of Perampanel Tablets 10mg
Fycompa 10Mg TabletDrug
1 tablet of Perampanel Tablets 10mg
| Study group | Role | What they receive |
|---|---|---|
| Perampanel Tablets | Experimental | Perampanel 10mg Tablets Receives: Drug: Perampanel 10 MG |
| Fycompa film-coated tablets | Active comparator | Fycompa 10mg film-coated tablets (Perampanel 10mg) Receives: Drug: Fycompa 10Mg Tablet |
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.
- First posted10 Jun 2024
- Study start22 Nov 2023
- Primary completion26 Nov 2023
- Study completion6 Feb 2024
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)
Sponsor and investigators
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450236
- Sponsor's protocol ID
- PR/BE/23/228
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 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 10 mg of Humanis Sağlık A.Ş., Turkey and Fycompa 10 mg Film-coated Tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Deutschland in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
- ClinicalTrials.gov ID
- NCT06450236
- Acronym / sponsor ID
- PR/BE/23/228
- 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
- 22 Nov 2023 (actual)
- Primary completion
- 26 Nov 2023 (actual)
- Study completion
- 6 Feb 2024 (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.
An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single dose bioequivalence study of Perampanel Tablets 10 mg of Humanis Sağlık A.ġ., Turkey and Fycompa 10 mg film-coated tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Deutschland in normal, healthy, adult, human subjects under fasting condition.
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 10 MGPerampanel 10mg Tablets |
| Fycompa film-coated tablets | Active comparator | Drug: Fycompa 10Mg TabletFycompa 10mg film-coated tablets (Perampanel 10mg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Subjects fulfilling the following criteria were included in the study:
- 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);
Key exclusion criteria (19 listed)
- Subjects with the following criteria were excluded from the study:
- 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;
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 10 MG1 tablet of Perampanel Tablets 10mg | Drug | Perampanel Tablets |
| Fycompa 10Mg Tablet1 tablet of Perampanel Tablets 10mg | 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 10 Jun 2024.
- Individual participant dataSharing planned: No
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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.
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 10 MG and Fycompa 10Mg Tablet 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 15 inclusion and 19 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 10 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?
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 10 Jun 2024.