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临床试验/CTRI/2024/02/062873
CTRI/2024/02/062873尚未招募2 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.

Optimus Pharma Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
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试验速览

阶段
2 期
状态
尚未招募
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

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 18.50 - 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
  • •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.

排除标准

  • •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.
  • 另有 1 项未显示

研究者

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