CTRI/2020/05/025236已完成未知
A Randomized, Open-Label, Two-Period, Two-Treatment, Two-Sequence, Crossover, Multiple-Dose, Steady State, Multicenter, Bioequivalence Study of Vigabatrin Tablet USP 500 mg of Zydus Worldwide DMCC, United Arab Emirates with Sabril® (Vigabatrin) Tablet 500 mg of Lundbeck, Deerfield, IL 60015, USA in Subjects with Refractory Complex Partial Seizures Under Fasting Condition.
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1) Male or non-pregnant or non-lactating female aged between >= 18 to <= 55 years with refractory complex partial seizures.
- •2) The subject has refractory complex partial seizure as evidenced by the attainment of all the following criteria:
- •a) The subject has failed because of lack of efficacy with 2 or more antiepileptics administered as monotherapy or polytherapy.
- •b) The subject should be taking at least 1 AED (A vagal nerve stimulator is not counted as an AED)
- •3) Currently stable on a regimen consisting of Vigabatrin tablet 500 mg twice daily for at least 28 days as adjunctive therapy and likely to continue the same dose in the study.
- •4) Subject with Body Mass Index (BMI) >= 18 to <= 30kg/m2. BMI values should be rounded to the nearest integer (e.g. 30.4 rounds down to 30, while 17.5 rounds up to 18).
- •5) Subject with adequate hematopoietic and liver function defined as:
- •a) Hemoglobin of >= 9.0 g/dL
- •b) Platelet count >= 100,000/mm3
- •c) AST and ALT <= 3 times ULN, Alkaline phosphatase <= 2.5 times ULN, Bilirubin <= 1.5 times ULN.
- •6) Subject with a estimsted creatinine clearance of > 80 mL/min.
- •7) Subject with clinically non-significant findings on ophthalmologic
- •assessments for visual field and visual acuity.
- •8) Male and female subjects must agree to use acceptable contraceptive methods from screening to end of study.
- •9) Willing to provide informed consent to participate in this study.
- •10) Able to comply with protocol requirements and assessments.
排除标准
- •1) History of hypersensitivity to Vigabatrin or any ingredients of the
- •formulation.
- •2) Pre-existing ocular or neurological disease that might affect bilateral visual field or interference with perimetry (e.g. aphakia, visually significant cataract, glaucoma, diabetic retinopathy, ischemic optic neuropathy, multiple sclerosis).
- •3) Concurrent exposure to medication with known or suspected retinal or optic nerve toxicity (e.g. deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol).
- •4) Subject with suicidal ideation (score of 4 or 5 on the Columbia Suicide Severity Rating Scale [C-SSRS]) within the past 2 months or any suicidal behavior occurring in the past year.
- •5) Presence of primary generalized epilepsy or seizures, such as absence seizures and/or myoclonic epilepsy.
- •6) Subject with peripheral neuropathy.
- •7) Presence or previous history of Lennox-Gastaut syndrome.
- •8) A history of status epilepticus within approximately 6 months prior to randomization.
- •9) A history of psychogenic seizures.
- •10) Suffering from psychotic disorder(s) and/or unstable recurrent affective disorder(s) evident by use of antipsychotics within the last 2 years.
- •11) Expected changes in concomitant medications during the period of
- •12) Ingestion of any alcohol or alcoholic food, caffeine or xanthine containing food or beverage, recreational drugs within the 48 hours prior to first dosing of Day 1 of period I.
- •13) Consumption of red wine, seville oranges, grapefruit or grapefruit juice, (pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices) within 7 days prior to first dosing of Period I.
- •14) Presence of a progressive central nervous system CNS disease,including degenerative CNS diseases.
- •15) Major surgery of the gastrointestinal tract, the liver or kidney within 6 months prior to randomization which may affect the pharmacokinetics of Vigabatrin.
- •16) Subject unable to swallow orally administered medication or with
- •gastrointestinal disorders likely to interfere with absorption of the study medication.
- •17) A positive test result for Hepatitis (includes subtypes B & C), HIV
- •and/or Syphilis (RPR/VDRL).
- •18) Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days or difficulty in accessibility of veins.
- •19) Subject received any investigational drug within the past 30 days of screening.
- •20) History of drug or alcohol dependency or abuse within the last 2 years of screening.
- •21) Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (e.g., Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
- •22) History of any significant cardiovascular, renal, hepatic, neurologic, endocrine dysfunction, inflammatory bowel disease, cancer, or any other condition which in the opinion of the investigator, may put the subject at risk because of participation in the study.
- •23) Subject who is institutionalized.
- •24) Any other condition that, in the investigatorâ??s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
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