Examination of the Pharmacokinetic Properties of Two Generic Antidepressants and Their Respective Brand Preparations in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Blood levels of drugs and their metabolite (when appropriate) will be evaluated for both the generic and the brand name medication.
研究概览
简要总结
Generic medications should be the equivalent of brand medications with the exception of their price. Before a generic medication is introduced, its bioequivalence within a window of 80 to 125% of the original has to be demonstrated. There are reports that this criterion is not always followed in post-marketed periods. Such investigations were triggered by the observation that some patients previously stable on original medications relapsed when switched to a presumable equivalent generic. Several factors could account for this problem. Given reports of such problems occurring with the antidepressants citalopram and venlafaxine, some pharmacokinetic properties of specific brands of generics and the originals will be examined for these two medications. Twelve healthy male volunteers will participate in this crossover study. It is anticipated that there will be significant differences emerging between the two formulations given the clinical reports of patients deteriorating when switched from the original to the generic preparations.
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
- 是
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 urine/blood analysis (sodium, potassium, chloride, creatinine, urea, ALT, AST, total protein, glucose, and TSH)
研究组 & 干预措施
1
Crossover Effexor / NOVO-Venlafaxine
Examination of the bioequivalence of Effexor (Wyeth Pharmaceuticals) and NOVO-Venlafaxine (NOVOPHARM).
Both drugs will be given at the dose of 75 mg/day (one capsule per day) for 4 consecutive days. A washout period (corresponding to 10 half-life of the active metabolite desmethylvenlafaxine) will be respected after receiving each medication.
干预措施: Venlafaxine (Drug)
1
Crossover Effexor / NOVO-Venlafaxine
Examination of the bioequivalence of Effexor (Wyeth Pharmaceuticals) and NOVO-Venlafaxine (NOVOPHARM).
Both drugs will be given at the dose of 75 mg/day (one capsule per day) for 4 consecutive days. A washout period (corresponding to 10 half-life of the active metabolite desmethylvenlafaxine) will be respected after receiving each medication.
干预措施: Effexor XR (Drug)
2
Crossover Celexa/Gen-citalopram
Examination of the bioequivalence of Celexa (Lundbeck, Brand Name) and Gen-Citalopram (Genpharm, Generic). Both drugs will be given at the dose of 40 mg/day (one tablet per day) for 8 consecutive days. A washout period (corresponding to 10 half-life of citalopram) will be respected after receiving each medication.
干预措施: Gen-Citalopram (Drug)
2
Crossover Celexa/Gen-citalopram
Examination of the bioequivalence of Celexa (Lundbeck, Brand Name) and Gen-Citalopram (Genpharm, Generic). Both drugs will be given at the dose of 40 mg/day (one tablet per day) for 8 consecutive days. A washout period (corresponding to 10 half-life of citalopram) will be respected after receiving each medication.
干预措施: Celexa (Drug)
结局指标
主要结局
Blood levels of drugs and their metabolite (when appropriate) will be evaluated for both the generic and the brand name medication.
时间窗: 1 month
次要结局
未报告次要终点