CTRI/2024/02/062873已完成2/3 期
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.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •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).
- •Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording.
- •Subjects having a normal or clinically not significant chest X-Ray (P/A view).
- •A negative urine screen result for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).
- •A negative alcohol urine test or alcohol breath test result.
- •Subject able to communicate effectively and provide written informed consent.
- •Subjects willing to adhere to the protocol requirements as evidenced by written informed consent approved by ethics committee.
- •Subjects that can provide adequate evidence of their identity.
- •Availability of volunteer for the entire study duration.
- •Ability to fast for at least 14.00 hours and consume standard meals. In case of Female subjects:
- •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.
- •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.
排除标准
- •If any subject is having any of the following conditions, then exclude him her from participation in this study:
- •Known hypersensitivity to Brivaracetam or other pyrrolidone derivatives to related drugs or any component of this medication.
- •Incapable of understanding the informed consent information
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •At imminent risk of injuring self or others or causing significant damage to property, as judged by the Investigator.
- •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.
- •Smokers who smoke more than 9 cigarettes per day.
- •Alcoholic who consumes more than 21units (210 mL) of alcohol in a week.
- •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within one month of starting the study.
- •History or presence of alcoholism or drug abuse.
- •History or presence of asthma, urticaria or other allergic reactions.
- •History or presence of gastric and or duodenal ulceration.
- •History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion.
- •History or presence of cancer.
- •Difficulty with donating blood.
- •Difficulty in swallowing solids like tablets or capsules.
- •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.
- •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.
- •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.
- •Major illness during the 90 days before screening.
- •Participation in a drug research study within 90 days of screening.
- •Donation of blood within 90 days of screening.
- •Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL.
- •Abnormal diet pattern for whatever reason (e.g. low sodium, fasting, and high protein diets) during the four weeks preceding the study
- •Pregnant woman and nursing mothers.
- •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.
- •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.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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.)
研究者
Dr Harisha C
Notrox Research Pvt. Ltd.
研究点 (1)
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