CTRI/2024/02/062873 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On:
19/02/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
A study to evaluate the blood levels of Brivaracetam SR Tablets 200 mg to measure the pharmacokinetic profiles, safety and tolerability of the Test product (of Optimus Pharma Pvt. Ltd.) when compared to the reference product (BRITZILAM SR Tablets 200 mg) in a healthy subject in a fasting condition.
Scientific Title of Study
An Open Label, Randomized, Balanced, Two-Treatment, Two-Sequence, Two-Period, Crossover, Single-Dose, oral bioequivalence study of Brivaracetam Sustained Release Tablets 200 mg (T) Manufactured by Optimus Pharma Pvt. Ltd., India with BRITZILAM SR (Brivaracetam Sustained Release Tablets 200 mg) (R) Manufactured by Ravenbhel Healthcare Pvt. Ltd., India and Marketed by Torrent Pharmaceuticals Ltd., India in healthy, adult, human subjects under fasting conditions.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.:S-23-798, Version 01 Dated 19.06.2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Harisha C
Designation
Principal Investigator
Affiliation
Notrox Research Pvt. Ltd.
Address
Notrox Research Pvt. Ltd.
2nd Floor.
Bikasipura road, JC Industrial layout. Off Kanakapura
Road (Behind Metro Cash and carry) Bangalore KARNATAKA 560085 India
Optimus Pharma Pvt. Ltd. Plot No. 73B, 73B2, EPIP, Pashamylaram Village, Patancheru (Mandal), Sangareddy District, Hyderabad-502307, Telangana, 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 Harisha C
Notrox Research Private Limited
No 19 3,2nd Floor, Bikasipura road,
JC Industrial layout, off Kanakapura Road (Behind Metro Cash & carry)
Bangalore -560062,
Karnataka,
India. Bangalore KARNATAKA
8183086951
harisha-c@notroxresearch.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Sri Durgamba Independent ethics committee
Approved
Regulatory Clearance Status from DCGI
Status
No Objection Certificate
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy Adult Human Subjects
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
BRITZILAM SR (Brivaracetam Sustained Release Tablets 200 mg)
After an overnight fasting of at least 10.00 hours, a single dose of BRITZILAM SR (Brivaracetam Sustained Release Tablets 200 mg) Manufactured by Ravenbhel Healthcare Pvt. Ltd., India and Marketed by Torrent Pharmaceuticals Ltd., India along with 240±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.
Subjects will receive the alternate ‘treatment’ in the subsequent periods, in such a way that each subject will have received all the ‘treatments’ by the end of the study.
Intervention
Brivaracetam Sustained Release Tablets 200 mg
After an overnight fasting of at least 10.00 hours, a single dose Brivaracetam Sustained Release Tablets 200 mg Manufactured by Optimus Pharma Pvt. Ltd., India along with 240±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.
Subjects will receive the alternate ‘treatment’ in the subsequent periods, in such a way that each subject will have received all the ‘treatments’ by the end of the study.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
Volunteers who accept for participating in this study must:
1.Healthy, willing, human subjects (Male and/or non-pregnant, non-lactating
female) aged between 18 and 45 years (inclusive of both).
2.Male agreeing to use appropriate contraceptive measures like Double Barrier
method (condom + diaphragm, condom or diaphragm + spermicidal gel or
foam), and should not donate sperm etc. during study and 07 days after
completion of study.
3.Subjects with a BMI between 18.50 - 29.99 kg/m2 (inclusive of both).
4.Subjects in normal health as determined by personal medical history, clinical
examination including vital signs and clinically acceptable results of
laboratory examinations (including serological tests).
5. Subjects having a normal or clinically not significant 12-lead
electrocardiogram (ECG) recording.
6. Subjects having a normal or clinically not significant chest X-Ray (P/A view).
7. A negative urine screen result for drugs of abuse (including amphetamines,
barbiturates, benzodiazepines, marijuana, cocaine and morphine).
8. A negative alcohol urine test or alcohol breath test result.
9. Subject able to communicate effectively and provide written informed
consent.
10. Subjects willing to adhere to the protocol requirements as evidenced by written
informed consent approved by ethics committee.
11. Subjects that can provide adequate evidence of their identity.
12. Availability of volunteer for the entire study duration.
13. Ability to fast for at least 14.00 hours and consume standard meals.
In case of Female subjects:
14. Female subjects who are of child bearing potential and are willing to use a
suitable and effective double barrier contraceptive method or non-hormonal
intra uterine device during the study.
15. Female subjects who are tested negative for serum pregnancy test at the time
of check-in.
16.Female subjects who are tested negative for urine pregnancy test at the time
of screening.
ExclusionCriteria
Details
If any subject is having any of the following conditions, then exclude him her from
participation in this study:
1. Known hypersensitivity to Brivaracetam or other pyrrolidone derivatives to
related drugs or any component of this medication.
2. Incapable of understanding the informed consent information
3. History or presence of significant cardiovascular, pulmonary, hepatic, renal,
gastrointestinal, endocrine, immunological, dermatological, neurological or
psychiatric disease or disorder.
4. Active suicidal or homicidal intent (as per Investigator’s opinion) or a prior
suicide or homicide attempt in the past 2 years.
5. At imminent risk of injuring self or others or causing significant damage to
property, as judged by the Investigator.
6. Ingestion of any medicine at any time within 14 days prior to IP administration
in period I. In any such case subject selection will be at the discretion of the
principal investigator.
7. Smokers who smoke more than 9 cigarettes per day.
8. Alcoholic who consumes more than 21units (210 mL) of alcohol in a week.
9. Any treatment which could bring about induction or inhibition of hepatic
microsomal enzyme system within one month of starting the study.
10. History or presence of alcoholism or drug abuse.
11. History or presence of asthma, urticaria or other allergic reactions.
12. History or presence of gastric and or duodenal ulceration.
13. History or presence of thyroid disease, adrenal dysfunction, organic
intracranial lesion.
14. History or presence of cancer.
15. Difficulty with donating blood.
16. Difficulty in swallowing solids like tablets or capsules.
17. Use of any prescribed medication (including herbal remedies and vitamins)
during the two weeks before the start of the study or OTC medicinal products
(including herbal remedies and vitamins) during one week prior to study
initiation and throughout the study.
18. Subject consumed tobacco tobacco containing products, pan or pan masala,
gutkha, masala (containing betel nut and tobacco) for at least 48.00 hours prior
to initiation of the study and throughout the study.
19. Subject consumed caffeine and or xanthine-containing foods or beverages (i.e.
coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), grape fruit
and/or grape fruit juice and poppy containing foods for at least 48.00 hours
prior to initiation of the study and throughout the study.
20. Major illness during the 90 days before screening.
21. Participation in a drug research study within 90 days of screening.
22. Donation of blood within 90 days of screening.
23. Positive screening test result for any one or more of the following: HIV,
Hepatitis B, Hepatitis C and VDRL.
24. History or presence of easy bruising or bleeding.
25. Abnormal diet pattern for whatever reason (e.g. low sodium, fasting, and high
protein diets) during the four weeks preceding the study
26. Pregnant woman and nursing mothers.
27. Female volunteer who has used implanted or injected hormonal contraceptives
anytime during the 6 months prior to study or used hormonal contraceptives
within 14 days before dosing.
28. Woman of child bearing age who do not agree to follow a reliable method of
contraception during study period.
Prior to check-in of Period-One, complete the Inclusion and Exclusion Criteria for each volunteer. Only suitable
volunteers should be allowed to participate in the study.
Method of Generating Random Sequence
Method of Concealment
Blinding/Masking
Primary Outcome
Outcome
TimePoints
To compare and assess the rate and extent of absorption of Brivaracetam Sustained Release Tablets 200 mg (T) Manufactured by Optimus Pharma Pvt. Ltd., India with BRITZILAM SR (Brivaracetam Sustained Release Tablets 200 mg) (R) Manufactured by Ravenbhel Healthcare Pvt. Ltd., India and Marketed by Torrent Pharmaceuticals Ltd., India.
Total 25 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 3.0 mL will be collected in each period. The pre-dose and post-dose blood samples will be collected in pre-labeled K2EDTA vacutainers.
The post-dose blood samples of 3.0 mL will be collected in Ice cold bath at 00.17, 00.25, 00.50, 00.75, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose.
Secondary Outcome
Outcome
TimePoints
To monitor the adverse events & to ensure the safety of the subjects following administration of a single dose of Brivaracetam Sustained Release Tablets 200mg
Total 25 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 3.0 mL will be collected in each period. The pre-dose & post-dose blood samples will be collected in pre-labeled K2EDTA vacutainers.
The post-dose blood samples of 3.0 mL will be collected in Ice cold bath at 00.17, 00.25, 00.50, 00.75, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00, 36.00 & 48.00 hours post-dose.
Target Sample Size
Total Sample Size="24" Sample Size from India="24" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Phase of Trial
Phase 2/ Phase 3
Date of First Enrollment (India)
29/02/2024
Date of Study Completion (India)
Date Missing
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="6" 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
An Open Label,
Randomized, Balanced, Two-Treatment, Two-Sequence, Two-Period, Crossover,
Single-Dose, oral bioequivalence study of Brivaracetam Sustained Release
Tablets 200 mg (T) Manufactured by Optimus Pharma Pvt. Ltd., India with
BRITZILAM SR (Brivaracetam Sustained Release Tablets 200 mg) (R) Manufactured
by Ravenbhel Healthcare Pvt. Ltd., India and Marketed by Torrent
Pharmaceuticals Ltd., India in healthy, adult, human subjects under fasting
conditions.
Primary
objective:
To compare and
assess the rate and extent of absorption of Brivaracetam Sustained Release
Tablets 200 mg (T) Manufactured by Optimus Pharma Pvt. Ltd., India with
BRITZILAM SR (Brivaracetam Sustained Release Tablets 200 mg) (R) Manufactured
by Ravenbhel Healthcare Pvt. Ltd., India and Marketed by Torrent
Pharmaceuticals Ltd., India.
Secondary
objective:
To
monitor the adverse events and to ensure the safety of the subjects following
administration of a single dose of Brivaracetam Sustained Release Tablets
200mg.