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临床试验/TCTR20170606001
TCTR20170606001尚未招募1 期

An Open-label, Single-dose, Two-treatment, Two-period, Two-sequence, Randomized, Crossover Bioequivalence Study of 100 mg Topiramate Tablets between Test and Reference Product (Topamax® (100 mg)) in Healthy Thai Male Volunteers under Fasting Conditi

Siriraj Clinical Research Center0 个研究点目标入组 28 人开始时间: 2017年6月6日最近更新:
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适应症

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
28
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

年龄范围
18 Years 至 45 Years（—）
性别
Male

入选标准

  • •1.Thai male age between 18-45 years
  • •2.Has body mass index (BMI) between 18.0-25.0 kg/m2
  • •3.Has been determined healthy by physical examination, assessment of drug abuse, medical history, and vital signs
  • •4.Has normal or acceptable results (being assessed as clinically non-significant by the clinical investigator) for all screening tests including: complete blood count (CBC), fasting blood sugar (FBS), aspartate aminotransferase (AST or SGOT), alanine aminotransferase (ALT or SGPT), alkaline phosphatase (ALP), total bilirubin, blood urea nitrogen (BUN), serum creatinine (Cr) and urinalysis
  • •5.Has negative result for hepatitis B viral profile (HBsAg)
  • •6.Has normal or acceptable report (being assessed as clinically non-significant by the clinical investigator) for EKG
  • •7.Using effective contraception after the first dosing and continue until 7 days after the end of study
  • •8.Has ability and intention to comply with the requirement of study and available for the whole study period
  • •9.Willing to participate and voluntarily signed the informed consent form prior to participate the study

排除标准

  • •1.History of allergic reaction to topiramate and/or related structure and/or its constituents.
  • •2.Has history or concurrent symptoms of allergy, cardiovascular, liver, kidney, gastrointestinal, hematological disorders and/or any disease that may affect the bioavailability of the drug.
  • •3.Regularly alcohol consumption (more than 1 time/week) and cannot abstain for at least 3 days prior to dosing.
  • •4.Alcohol breath test before admission show alcohol concentration more than 0 mg%.
  • •5.A smoker or non-smoker less than 30 days
  • •6.Use of any drugs (except paracetamol) especially which can affect cytochrome P450 enzymes (enzyme inducers e.g., phenobarbital, phenytoin, rifampicin and/or enzyme inhibitors e.g., cimetidine, ketoconazole, erythromycin) within 14 days prior to the first dosing and willing to taking them throughout participation period
  • •7.Use of paracetamol within 3 days prior to dosing and until after the last sample is collected in each period (Paracetamol taken during this prohibition period can be approved under the consideration of principal investigator or clinical investigator)
  • •8.Use of food supplements, vitamins, minerals and/or herbal remedies within 14 days before the first dosing and willing to taking them throughout participation period
  • •9.Has drink containing xanthine derivatives or xanthine-related compounds (e.g. coffee, tea, colas, chocolate, caffeine-containing sodas and decaffeinated products) for at least 3 days prior to dosing and until after the last sample is collected in each period.
  • •10.Has drink or food containing grapefruit and/or orange and/or pomegranate compound for at least 3 days prior to dosing and until after the last sample is collected in each period.
  • •11.Following a special diet (e.g., vegetarian) or dieting one month before the study initiation.
  • •12.Has history of problem in swallowing tablet
  • •13.A participant in other clinical studies within last 30 days prior to the first dosing
  • •14.Has blood donated and/or blood loss more than 350 mL within last 90 days

研究者

发起方
Siriraj Clinical Research Center

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