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临床试验/NCT01400165
NCT01400165Unknown1 期

Examination of the Pharmacokinetic Properties of Three Generic Medications and Their Respective Brand Preparations in Healthy Male Volunteers

University of Ottawa1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
30
试验地点
1
主要终点
Plasma levels of Medication

研究概览

简要总结

Generic describes a pharmaceutical product that does not have a brand name or trademark. Generic medications should be the equivalent of brand medications. Only their price should be different. The active ingredient of the generic medication has to be within a window of 80 to 125% of the original in the blood. There are reports that this standard is not always followed after the medication has been on the market. Indeed, it was observed that some patients previously stable on original medications relapsed when switched to a generic. Several factors could account for this problem. Such problems have been reported for Pindolol, Quetiapine, and Trazodone. Some properties of specific brands of the generics and the original brands will be examined for these three medications. The three original medications used in this study are the Visken, the Seroquel, and the Desyrel. The three generics are the Teva-pindolol, the Teva-Quetiapine, and the Teva-Trazodone. They are all available on the Canadian market by prescription.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)

排除标准

  • Psychiatric disorder
  • Hepatic disease
  • Renal disease
  • Gastrointestinal disease
  • Hematological disease
  • Physical and/or neurological disease
  • Positive urine drug screen
  • Abnormal blood pressure
  • Abnormal Electrocardiogram
  • Abnormal urine/blood analysis (sodium, potassium, chloride, creatinine, urea, ALT, AST, total protein, glucose, and TSH)
  • Taking medication
  • Have donated 50 mL to 499 mL whole blood within 30 days and more than 499 mL whole blood within 56 days preceding entry into this study

研究组 & 干预措施

Desyrel/Teva-Trazodone

Active Comparator

Both drugs will be given at the dose of 150 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication.

干预措施: Trazodone (Drug)

Desyrel/Teva-Trazodone

Active Comparator

Both drugs will be given at the dose of 150 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication.

干预措施: Blood Collection (Procedure)

Visken/Teva-Pindolol

Active Comparator

Both drugs will be given at the dose of 10 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication

干预措施: Pindolol (Drug)

Visken/Teva-Pindolol

Active Comparator

Both drugs will be given at the dose of 10 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication

干预措施: Blood Collection (Procedure)

Seroquel/Teva-Quetiapine

Active Comparator

Both drugs will be given at the dose of 100 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication

干预措施: Quetiapine (Drug)

Seroquel/Teva-Quetiapine

Active Comparator

Both drugs will be given at the dose of 100 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication

干预措施: Blood Collection (Procedure)

结局指标

主要结局

Plasma levels of Medication

时间窗: 0 to 48 hours after drug ingestion

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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