CTRI/2025/11/097939 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On:
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, bioequivalence study of Test product (T): Vonoprazan Tablets 20 mg of Eris Lifesciences Limited, India with Reference product (R): Takecab® Tablets 20 mg of Takeda
Pharmaceutical Company Limited, 1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo, Japan, in healthy, adult, human subjects under fasting conditions.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
SY/25/19, Version 01, dated 17 Sep 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,
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,
Ahmadabad GUJARAT 380054 India
Phone
9676559480
Fax
Email
ganesh.boddu@erislifesciences.com
Source of Monetary or Material Support
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 Volunteers
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Takecab® (Vonoprazan 20 mg Tablet), Manufactured by Takeda Pharmaceutical Company Limited. One Tablet dosed of Takecab® (Vonoprazan 20 mg Tablet and Total duration of study is 11 days.
After an overnight fasting of at least 08.00 hours, a single dose of Takecab®(Vonoprazan 20 mg) Tablet (R) Manufactured by Takeda Pharmaceutical Company Limited, Japan 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 11 days from the day of check-in of the first period till the Last sample of the second period.
Intervention
Vonoprazan 20 mg Tablet, Manufactured by Eris Lifesciences Limited. One Tablet dosed of Vonoprazan 20 mg and Total duration of study is 11 days
After an overnight fasting of at least 08.00 hours, a single dose of Vonoprazan 20 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 11 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 (Male and female), 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 48 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 ALT and AST), urinalysis, 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 Vonoprazan 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. Abnormal liver function test during the screening.
10. Subjects with positive result of HIV tests or HBsAg or Hepatitis-C tests during screening.
11. Found positive in breath alcohol test and/or urine test for drug abuse.
12. History of problems in swallowing of tablet/capsule.
13. Any contraindication to blood sampling.
14. 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-t) and AUC(0-inf)
Total number of blood samples: 22 samples per period.
Sampling: Pre dose 00.00 hr. [(4 mL) collected within 01.00 hour prior to dosing] and post dose of 4 mL at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 05.00, 06.00,08.00, 10.00, 12.00, 16.00, 24.00 and 48.00 hrs. Post-dose. Blood samples will collected in K2EDTA Vacutainer.
Secondary Outcome
Outcome
TimePoints
AUC% extrapolation, Kel, Tmax and t1/2
Total number of blood samples: 22 samples per period.
Sampling: Pre dose 00.00 hr. [(4 mL) collected within 01.00 hour prior to dosing] and post dose of 4 mL at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 05.00, 06.00,08.00, 10.00, 12.00, 16.00, 24.00 and 48.00 hrs. Post-dose. Blood samples will collected in K2EDTA Vacutainer.
Target Sample Size
Total Sample Size="24" Sample Size from India="24" Final Enrollment numbers achieved (Total)= "24" Final Enrollment numbers achieved (India)="24"
Phase of Trial
N/A
Date of First Enrollment (India)
04/12/2025
Date of Study Completion (India)
10/12/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
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.
Before every post dose blood sample collection, 0.2 mL of heparinized blood present in the intravenous cannula will be discarded during the use of the intravenous cannula. Also, after every blood sample collection, 0.2 mL of heparinized saline will be injected into the intravenous cannula.
Total number of blood samples: 22 samples per period.
Sampling: Pre dose 00.00 hr. [(4 mL) collected within 01.00 hour prior to dosing] and post dose of 4 mL at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00 and 48.00 hrs. Post-dose. Blood samples will collected in K2EDTA Vacutainer. Blood samples after 24.00 hrs. will be collected on ambulatory basis.
Considering the minimum washout period 07 days, expected study duration of clinical part is 11 days from the day of check-in of first period till the day of last period study sample