NCT00975325已完成4 期
Characterisation of Relative Bioavailability and Assessment of Bioequivalence of Two Generic Yohimbine Formulations in Comparison With a Marketed Reference Product - an Open, Randomised, Single Dose, 3-period Change-over Study
Walter Ritter GmbH & Co1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter AUC, Cmax
研究概览
简要总结
-
Type: Bioequivalence study in male healthy volunteers, therapeutical indication (erectile disfunction) not studied
-
Products, dosage, and route of administration:
-
Test 1: Yohimbin "Spiegel"® (Desma GmbH, Germany), tablet containing 5 mg yohimbine hydrochloride, oral administration
-
Reference: Yocon-Glenwood® (Glenwood GmbH, Germany), tablet containing 5 mg yohimbine hydrochloride, oral administration
-
Duration of treatment:
2 single-dose administrations of 5 mg yohimbine hydrochloride each under fasting conditions separated by a wash-out period of at least one week i.e. 6 treatment free days between all administrations
详细描述
Study objectives
Primary Objectives:
- Characterisation of relative bioavailability of Test 1 in comparison to Reference after single dose administration under fasting conditions
- Assessment of bioequivalence of Test 1 vs. Reference after single dose administration under fasting conditions, determined by use of area under the concentration time curve AUC0-tlast and maximal concentration Cmax obtained for yohimbine
Secondary Objective:
- Descriptive characterisation of safety and tolerability of the investigational products in the study population
- Descriptive characterisation of blood pressure and pulse rate around Cmax of the investigational products in the study population
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Sex: male
- •Ethnic origin: Caucasian
- •Age: 18 - 55 years, inclusive
- •Body-mass index1 (BMI): ≥ 19 kg/m² and ≤ 27 kg/m²
- •Good state of health
- •Non-smoker or an ex-smoker for a least 1 month
- •Written informed consent, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study
排除标准
- •Safety concerns:
- •Existing cardiac or haematological diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
- •Existing hepatic and/or renal diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
- •Existing gastrointestinal diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
- •History of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- •Pathological ECG (12 standard leads) which might interfere with the safety of the active ingredient
- •Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
- •Subjects with severe allergies or multiple drug allergies
- •Systolic blood pressure <100/>140 mmHg
- •Diastolic blood pressure <60/>90 mmHg
- •Pulse rate <45/>110 bpm
- •Laboratory values out of normal range unless the deviation from normal is judged as not relevant for the study by the investigator
- •Positive anti-HIV-test, HBs-AG-test or anti-HCV-test
- •History of glaucoma
- •Lack of suitability for the trial
- •Subjects exhibiting extreme genetic polymorphism of CYP 2D6 - "Poor or Ultra-rapid metabolizer"
- •Acute or chronic diseases which could affect absorption or metabolism
- •History of or current drug or alcohol dependence
- •Regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male per day
- •Subjects who are on a diet which could affect the pharmacokinetics of the active ingredient
- •Regular intake of caffeine containing food or beverages of ≥ 500 mg per day
- •Blood donation or other blood loss of more than 400 ml within the last two months prior to individual enrolment of the subject
- •Participation in a clinical trial during the last two months prior to individual enrolment of the subject
- •Regular treatment with any systemically available medication (except continuous usual replacement therapy e.g. L-thyroxine) within two weeks prior to the first administration of the study medication
- •Intake of yohimbine for any reason (e.g. fat burning, weight reduction, muscle improvement, post operative care and/or any therapy for erectile dysfunctions) within two weeks prior to first administration of the study medication
- •Subjects, who report a frequent occurrence of migraine attacks
- •Administrative reasons
- •Subjects suspected or known not to follow instructions
- •Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the study
研究组 & 干预措施
Yohimbine, Yohimbine "Spiegel"
Active Comparator
干预措施: Yohimbine (Drug)
Yohimbine Yocon-Glenwood
Active Comparator
干预措施: Yohimbine (Drug)
结局指标
主要结局
Pharmacokinetic parameter AUC, Cmax
时间窗: Day 1
次要结局
未报告次要终点
研究者
研究点 (1)
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