CTRI/2025/10/095956 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On:
18/11/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
A study in healthy volunteers to compare how Cenobamate 12.5 mg tablets are absorbed in the blood when taken without food
Scientific Title of Study
A randomized, open label, balanced, two treatment, two period, two sequence, single dose, crossover, truncated bioequivalence study of Test product (T): Cenobamate 12.5 mg Tablets of Eris Lifesciences Limited India with Reference product (R): XCOPRI® (cenobamate) 12.5 mg tablet Manufactured for SK Life Science, Inc., Paramus in Normal, Healthy, Adult, Human Subjects under fasting condition.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
SY/25/08, Version 01, dated 24 Apr 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Nirav Panchal
Designation
MBBS, Clinical Investigator
Affiliation
Sycon Clinical Research Pvt Ltd.
Address
Sycon Clinical Research Pvt. Ltd.
5th floor, Shree Sarju Arena, Opp. Kadi Nagrik Bank, Zundal, Gandhinagar-382421, Gujarat, India
Gandhinagar GUJARAT 382421 India
Phone
09879503898
Fax
Email
niravp@syconcro.com
Details of Contact Person Scientific Query
Name
Mr Ganesh Boddu
Designation
Head- Clinical Research and Regulatory Affairs
Affiliation
Eris Lifesciences Limited
Address
Eris Lifesciences Limited
Shivarth Ambit, Ramdas Road Off SBR Near Swati Bungalows, Bodakdev, Ahmedabad, Gujarat 380054, India
Ahmadabad GUJARAT 380054 India
Phone
9676559480
Fax
Email
ganesh.boddu@erislifesciences.com
Details of Contact Person Public Query
Name
Mr Ganesh Boddu
Designation
Head- Clinical Research and Regulatory Affairs
Affiliation
Eris Lifesciences Limited
Address
Eris Lifesciences Limited
Shivarth Ambit, Ramdas Road Off SBR Near Swati Bungalows, Bodakdev, Ahmedabad, Gujarat 380054, India
Eris Lifesciences Ltd, Shivarth Ambit, Ramdas Road Off SBR Near Swati Bungalows, Bodakdev,Ahmedabad,Gujarat 380054, India
Primary Sponsor
Name
Eris Lifesciences Ltd
Address
Plot No. 30-31, Brahmaputra Industrial Park, Village-Silla, Amingaon, North Guwahati, Dist-Kamrup, Assam-781031, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Nirav Panchal
Sycon Clinical Research Private Limited
5th floor, Shree Sarju Arena, Opp. Kadi Nagrik Bank, Zundal, Gandhinagar-382421, Gujarat, India. Gandhinagar GUJARAT
09879503898
niravp@syconcro.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Conscience Independent Ethics committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy human subjects, age in the range of 18 - 45 years both inclusive.
Intervention / Comparator Agent
Type
Name
Details
Intervention
Cenobamate 12.5 mg Tablet, Manufactured by Eris Lifesciences Limited. One Tablet dosed of Cenobamate 12.5 mg and Total duration of study is 21 days
After an overnight fasting of at least 08.00 hours, a single dose of Cenobamate 12.5 mg Tablet (T) Manufactured by Eris Lifesciences Ltd., India along with 240 mL ±2 mL of water, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule. The Total duration of the study for each subject will be 26 days from the day of check-in of the first period till the Last sample of the second period.
Comparator Agent
XCOPRI® (Cenobamate 12.5 mg Tablet), Manufactured by SK Life Science, Inc., Paramus. One Tablet dosed of XCOPRI® (Cenobamate 12.5 mg Tablet and Total duration of study is 21 days.
After an overnight fasting of at least 08.00 hours, a single dose of XCOPRI® (Cenobamate 12.5 mg) Tablet (R) Manufactured by Eris Lifesciences Ltd., India along with 240 mL ±2 mL of water, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule. The Total duration of the study for each subject will be 26 days from the day of check-in of the first period till the Last sample of the second period.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
(1) Healthy human subjects, age in the range of 18 - 45 years both inclusive.
(2) Body Mass Index between 18.5-30.0 Kg/m2 extremes included with minimum of 50 kg weight.
(3) Subjects with normal findings as determined by baseline history, physical examination and vital sign examination.
(4) Subjects with clinically acceptable findings as determined by haemogram, biochemistry including serum potassium, urinalysis, urine pregnancy test (for female subjects only), 12 lead ECG and chest X-ray (if done).
(5) Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 48.00 hours prior to dosing until the last blood sample collection in each study period and adherence to all study restrictions.
(6) No history of significant alcoholism.
(7) No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 06 months.
(8) Non-smokers as evident from the history obtained.
(9) Willing to provide written informed consent to participate in the study.
ExclusionCriteria
Details
(1) Known history of hypersensitivity to Cenobamate or related drugs or any of the excipients.
(2) Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days prior to dosing day.
(3) Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of IP.
(4) Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
(5) History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
(6) Not eligible as per Online Volunteer Information System (OVIS).
(7) Volunteer who have donated blood or experienced loss of blood of up to 150 ml within 30 days or 150 ml to 250 ml within 60 days or more than 250 ml within 90 days (exclude blood loss for screening) prior to first dose of study.
(8) History of malignancy or other serious diseases.
(9) History of hypersensitivity reactions including rash papular and pruritus.
(10) Subjects with positive result of HIV tests or HBsAg or Hepatitis-C tests during screening.
(11) Found positive in Columbia-Suicide Severity Rating Scale.
(12) Found positive in breath alcohol test and/or urine test for drug abuse.
(13) History of problems in swallowing of tablet/capsule.
(14) Any contraindication to blood sampling.
(15) Male human subjects not willing to use birth control measures, from the period-I dosing until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable.
(16) Use of hormonal contraceptives either oral or implants.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Cmax, AUC(0-72) and AUC(0-inf)
Total number of blood samples: 23 samples per period. Pre dose 00.00 hr. [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 3 mL at 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 4.50, 05.00, 05.50, 06.00, 08.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hrs post dose.
Secondary Outcome
Outcome
TimePoints
AUC% extrapolation, Kel, Tmax and t1/2
Total number of blood samples: 23 samples per period. Pre dose 00.00 hr. [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 3 mL at 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 4.50, 05.00, 05.50, 06.00, 08.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hrs post dose.
Target Sample Size
Total Sample Size="28" Sample Size from India="28" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
20/10/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A single oral dose of Test product (T) or Reference product (R) will be administered as per randomization schedule with 240 mL ± 2 mL of water at ambient temperature under fasting condition. Investigational products must be swallowed as whole and must not be chewed, crushed or divided. This activity will be followed by mouth check of the subjects to assess compliance to dosing. Principal investigator/ Clinical Investigator/ Clinical Co-Investigator/designee will oversee the dosing activity. Quality Assurance (QA) personnel will independently monitor the dosing activity. Total number of blood samples: 23 samples per period. Sampling: Pre dose 00.00 hr. [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 3 mL at 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 4.50, 05.00, 05.50, 06.00, 08.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hrs post dose. Blood samples will collected in K2EDTA Vacutainer.
Subjects will be fast overnight from at least 08.00 hours (hrs) before dose administration and for at least 04.00 hrs post-dose in each study period. Water will not allowed to the subjects for 01.00 hr pre dose to 01.00 hr post dose except dosing water given during administration of the dose. At all other times drinking water will be given ad-libitum. Subjects will remain in supine position for at least 06.00 hours after dosing. Only necessary movement will be allowed during this period.