CTRI/2018/07/014839尚未招募未知
A Multi- Centre, randomized, open label, multiple dose, two treatment, two-way steady state cross over, bioequivalence study comparing Felbamate oral suspension 600mg/5 mL of Glasshouse Pharmaceutical Limited Canada to the Reference Listed Drug(RLD), Felbatol (Felbamate) oral suspension 600mg/5mL in adult male and non-pregnant female epilepsy patients under fasting condition.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
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研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Male and Non Lactating , Non -Pregnant Female patients aged between 18-65years
- •2.Body Mass Index in the range of 18 â?? 30 kg/m2.
- •3.Patients diagnosed with Epilepsy who do not respond adequately to alternative treatment.
- •4.Patients must provide written Informed consent prior to any study related procedures being performed.
- •5. Patients must have a willingness and ability to comply with the protocol requirements
- •6. patients should not have clinically serious conditions as per Investigatorâ??s discretion as determined by physical examination, medical history and routine hematological and Biochemical tests.
- •7. patients agreeing to, not using or conforming to not having any medication (prescription and over the counter, herbal products), including vitamins and minerals for 15 days prior to study entry (screening) and during the course of the study except any one of Valproic acid, Gabapentin, Levetiracetam or Pregabalin for ongoing therapy of their illness.
- •8.Female patients of Childbearing potential, in addition to having a negative serum Pregnancy test, must be willing to use a reliable means of contraception (other hormonal contraceptives) eg: barrier method (diaphragm or condom with spermicide, jellies, foams, intrauterine device(IUD),etc), surgical sterilization (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or abstinence for the duration of the study. Hormonal contraceptives should be avoided within 2 months prior to study entry (screening)
排除标准
- •1.History of allergic reactions to felbamate and/or related drugs
- •2.Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia or idiopathic Parkinsonâ??s disease
- •3.Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt.
- •4.Change in AED regimen in the last 28 days
- •5.Subject is currently taking > 3 concomitant AEDs
- •6.Subject has had status epilepticus within the past 2 years
- •7.Epilepsy dietary therapy initiated < 3 months prior to enrollment
- •8.Epilepsy surgery < 1 year prior to enrollment
- •9.A two-fold increase in the highest, 2-day pre-study seizure frequency
- •10.Single generalized, tonic-clonic seizure, if none occurred during pre-treatment screening, and/or,
- •11.Significant prolongation of generalized, tonic-clonic seizures
- •12.Red Blood Cells (RBCs), White Blood Cells (WBCs) and platelet counts below the lower limit of normal for the laboratory conducting the test and / or as per Investigatorâ??s discretion
- •13.History of aplastic anemia or bone marrow suppression
- •14.Medical or surgical condition interfering with absorption, metabolism or excretion of felbamate
- •15.Serum transaminases > 2 multiply the upper limit of normal or history or evidence of hepatic dysfunction
- •16.Concurrent use of drugs known to suppress bone marrow function
- •17.Expected change of concomitant medications during trial
- •18.A history of severe hepatic impairment, drug inducted leucopenia/neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias and myocardial infarction or unstable heart disease
- •19.History of alcohol dependence, alcohol abuse or drug abuse within the past 6 months. Recent or current alcohol abuse ( > 5 units/week, 1 unit equal to 10 mL or 8 gm of pure alcohol) or suspected abuse.
- •20.Patients with positive HIV I/II, HCV tests
- •21.Patients with positive HBsAg, positive anti-Hbc and positive anti HBs
- •22.Participation in any other clinical study within 90 days prior to Compliance with outpatient medication schedule not expected.
- •23.History of or currently active malignancy or any other serious diseases
- •24.Any contraindication to blood sampling
- •25.Blood donation within 90 days prior to the commencement of the study
- •26.Patients who are unable to fulfill study requirements in relation to conforming to the visit schedule.
- •27.Onset of screening period
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