None listed
Conditions
Interventions
Intervention1: 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 Ph
Sponsors
Optimus Pharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Countries
India
Contacts
Public ContactDr D Sharmila
Optimus Pharma Pvt. Ltd.
Outcome results
None listed