EUCTR2009-011354-18-DE进行中（未招募）不适用
Randomised, open-label, comparative phase IV study on the bioavailability of Ciclosporin Pro (Teva) versus Sandimmun® Optoral (Novartis) under fasting versus fed conditions in patients with stable renal transplants - Food interaction with Ciclosporin Pro vs. Sandimmun® Optoral bioavailability
niversitätsklinikum Essen0 个研究点开始时间: 2009年12月28日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Signed informed consent
- •2.Male or female, aged >= 18 years
- •3.One or two renal transplants and at least 6 months post-transplantation
- •4.Maintenance treatment with Sandimmun® Optoral (with or without other immunosuppressive drugs), and regularly controlled by a transplantation centre
- •5.Stable individualised dose of ciclosporin and no change in immunosuppressive regimen for at least 2 months prior to study start
- •6.Stable graft function for at least 2 months and < 20% change in creatinine clearance (MDRD) for at least 1 month prior to study start
- •7.Female patients must be post-menopausal for >= 1 year, surgically sterilised, or women of childbearing potential must have a negative pregnancy test immediately prior to study entry, and meet the criteria for highly effective birth control with a low failure rate, i.e. less than 1% per year (e.g. implants, injectables, oral contraceptive steroids, intrauterine device, sexual abstinence, vasectomised partner). The investigator is responsible for determining whether the subject has adequate birth control for study participation.
- •8.Patient agrees to follow the study-specific instructions
- •9.Patient is able and willing (professional situation, family situation, planned holidays etc.) to come to the foreseen visits including four 13 hour-visits for the pharmacokinetic profiles
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.History of hypersensitivity to ciclosporin or any of the other excipients
- •2.Previous transplant with any organ other than kidney
- •3.Rejection episode within the past 6 months prior to the start of the study
- •4.Clinically relevant co-existing disease or other abnormal condition which may compromise function of gastrointestinal tract, kidney or liver or which could influence ciclosporin pharmacokinetic profiles
- •5.Active malignancy
- •6.Uncontrolled hypertension
- •7.Known or suspected significant hepatic impairment
- •8.Clinically significant hyperkalaemia (K+ > 6 mmol/l)
- •9.Clinically significant laboratory and/or physical changes during the last 2 months prior to the start of the study
- •10.Change in concomitant medication (drugs known to affect the pharmacokinetics of ciclosporin) during the past 2 months prior to study start
- •11.Any use of drug, prescribed or over-the-counter, (except stable concomitant medication) within 2 weeks prior to the first administration of study medication except this will not affect the outcome of the study in the opinion of the clinical investigator
- •12.Existing or intended pregnancy or breast feeding.
- •13.Any other condition of the patient that in the opinion of the investigator may compromise evaluation of the study treatment or may jeopardize patient’s compliance or adherence to protocol requirements
- •14.Previous enrolment in this study or participation in any other drug investigational trial within the past 2 months (or five half-lives whatever is longer) prior to enrolment or simultaneous participation in another clinical trial
研究者
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