ACTRN12607000008426已完成1 期
A Phase I, single dose, open, two-way crossover blood level study of vardenafil blood levels administered as LEVITRA 10mg oral tablets verses a single dose of vardenafil aqueous solution administered to healthy volunteers by inhalation using the IMT nebuliser
Intelligent Medical Technologies Pty. ltd.(IMT)0 个研究点目标入组 12 人开始时间: 2007年1月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Male
入选标准
- •Able to provide written informed consentAble to comply with the requirements of the studyAble to provide a permanent residential addressJudged as healthy by medical history, physical examination, an electrocardiogram (ECG) and laboratory screening within 28 days of study entryTest negative for hepatitis B and CNo evidence of drug or alcohol abuseWilling to abstain from taking any prescription or over-the-counter medication while in the clinical trial – all health supplements will be discontinued at least 7 days before the first treatmentAble to demonstrate comfortable cooperation” with nebulized administration of water using the IMT nebuliser
排除标准
- •Recent (within the last 12 months) serious medical illness or medical disorderHistory of cardiovascular diseaseAanatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease) or who have conditions which may predispose them to priapismKnown hereditary degenerative retinal disorders such as retinitis pigmentosa.Bleeding disorders or significant active peptic ulcerationSubject currently taking prescription medications of any typeIngestion of any vardenafil or related drugs in the 4 weeks prior to the day set for the Period 1 dose or during the study itself.· Ingestion of any other drug, including St John’s Wort, in the week prior to dosing or during the study itself which, in the opinion of the Medical Investigator, could compromise the study e.g. through pharmacokinetic or metabolic interactions, or analytical interference or provide a risk to the subjectCurrent infectionAbnormal findings on physical examinationPresence of any clinically significant abnormality in the ECGAbnormal screening laboratory values considered clinically significant by the investigatorDonation of blood within the last 60 daysParticipation in another clinical trial within the last 30 daysHistory of alcohol or drug abusesmokers or former smokers who have smoked within the immediately preceding 6 monthsIngestion of any alcohol, xanthines (i.e. tea, coffee, cola drinks, or chocolate) or grapefruit containing foods or beverages within the 24 hours prior to and the first 6 or 14 hours after dosing (in the dose-ranging and comparative pharmacokinetic studies respectively).Failure to conform to the requirements of the protocol.Detection of any of the proscribed drugs in the urine drug screenVital signs outside the reference range and clinically significantUrinalysis result outside the reference range and clinically significantSubjects with a history of asthma will be excluded. If Forced expiratory volume (FEV1) , forced expiratory volume (FVC) or FEV1 / FVC ratio is outside the normal range, the subject will be excluded.
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