CTRI/2025/04/084766 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On:
11/04/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
NA
Study Design
Randomized, Crossover Trial
Public Title of Study
A Study to evaluate the blood levels of Lacosamide 200 mg tablets (Mfg. by Eris Lifesciences Ltd) as a Test compared to the Reference MOTPOLY XR Tablets (Lacosamide 200 mg Mfg. by Acuta Pharmaceutical) tablets in a healthy subject under fasting conditions
Scientific Title of Study
A Randomized, open label, balanced, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Test product (T): Lacosamide SR 200 mg Tablet of Eris Lifesciences Limited India with Reference product (R): MOTPOLY XR (Lacosamide Extended Release) Capsules 200 mg Marketed by Aucta Pharmaceuticals, Inc. Piscataway in healthy, adult, human subjects under fasting condition.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
SY/24/24, Version 01, dated 08 Nov 2024
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 Private Limited
Address
5th floor, Shree Sarju Arena, Opp. Kadi Nagrik Bank, Zundal, Gandhinagar 382421, Gujarat, India
Ahmadabad GUJARAT 382421 India
Phone
9879503898
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 Lifescience 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 Lifescience 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
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
07935644895
niravp@syconcro.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
ACEAS 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
Intervention
Lacosamide Sustained Release Tablets 200 mg, Manufactured by Eris Lifesciences Limited. One Tablet dosed of Lacosamide 200 mg and Total duration of study is 10 days
After an overnight fasting of at least 10.00 hours, a single dose of Lacosamide SR 200mg 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 10 days from the day of check-in of the first period till the Last sample of the second period
Comparator Agent
MOTPOLY XR (Lacosamide Extended Release) Capsules 200 mg, Manufactured by Aucta Pharmaceuticals. One Tablet dosed of MOTPOLY XR (Lacosamide 200 mg) and Total duration of study is 10 days.
After an overnight fasting of at least 10.00 hours, a single dose of MOTPOLY XR (Lacosamide Extended Release) Capsules 200 mg (R) Manufactured by Aucta Pharmaceuticals USA 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 10 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 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, 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 Lacosamide 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 OVIS.
7. Volunteer who have donated blood or loss of blood up to 150 ml within 30 days or more
than 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 medication.
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: 25 samples per period. Sampling hrs: Pre dose [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 3 mL at 01.00, 02.00, 03.00, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 11.00, 12.00, 13.00, 14.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 hrs. Post-dose.
Secondary Outcome
Outcome
TimePoints
AUC% extrapolation, Kel, Tmax and t1/2
Total number of blood samples: 25 samples per period. Sampling hrs: Pre dose [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 3 mL at 01.00, 02.00, 03.00, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 11.00, 12.00, 13.00, 14.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 hrs. Post-dose.
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)
23/04/2025
Date of Study Completion (India)
15/07/2025
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. Subjects will be fast overnight from at least 10.00 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. Subjects will remain in supine position on bed for at least 08.00 hours after dosing. Only necessary movement will be allowed during this period.
Total number of blood samples: 25 samples per period. Sampling hrs: Pre dose [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 3 mL at 01.00, 02.00, 03.00, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 11.00, 12.00, 13.00, 14.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 hrs. Post-dose.
After collection, the blood samples will centrifuged at 3500 RPM for 5 minutes below 10°C to separate the plasma within 60 minutes of sample collection. Total time should not be exceed 90 minutes from blood collection to storage. The separated plasma will be transferred to a pre-labeled polypropylene tube in two aliquots (Analytical and control) [around 0.4 mL in the first aliquot (0.7 mL in case of pre-dose samples) and the remaining volume in the second aliquot] and stored in the deep freezer maintained at -20°C ± 5°C or colder temperature as soon as possible.