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.
- Registration Number
- CTRI/2024/02/062873
- Lead Sponsor
- Optimus Pharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 agre
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: 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. <br/ ><br> <br/ ><br>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 Measures
Name Time Method To monitor the adverse events & to ensure the safety of the subjects following administration of a single dose of Brivaracetam Sustained Release Tablets 200mgTimepoint: 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. <br/ ><br> <br/ ><br>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.