EUCTR2005-002157-51-DE进行中（未招募）不适用
A Phase II, Single-Center, Open-Label, Parallel, Three-Treatment, Single-Period, Randomized, Single and Multiple-Dose Pharmacokinetic Study of Oxybutynin Gel in Healthy Volunteers
Antares Pharma AG0 个研究点开始时间: 2005年6月30日最近更新:
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
- •a)Healthy subjects, aged 18 to 55 years. At least 70% of the subjects will be females. Females of childbearing potential should be using one of the following acceptable birth control methods:
- •·surgically sterile (tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
- •·IUD in place for at least 3 months;
- •·barrier methods (condom + spermicide, diaphragm with spermicide) for at least 14 days prior to the start of the study and throughout the study;
- •·surgical sterilization of the partner (vasectomy for 6 months minimum);
- •·hormonal contraceptives for at least 3 months prior to the start of the study.
- •b)Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests and electrocardiogram.
- •c)Body weight in defined relation to height. Body mass index 20 – 28 kg/m2.
- •d)No significant medical history or abnormal physical examination findings.
- •e)Informed consent signed by the subject after discussion and explanation of the study.
- •f)The subject is co-operative and available for the entire study.
- •g)No history of chronic medical illness or alcohol or drug abuse.
- •h)Abstinence from alcohol for 48 hours prior to each administration (as stated by subject). An alcohol breath test at the admission to the clinic on Days 1 and 20 must be negative.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a)Evidence in the subject's medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological or other significant acute or chronic abnormalities which might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the active agent under investigation.
- •b)Pregnancy (positive pregnancy test) or lactation.
- •c)Skin disease that might affect the oxybutynin absorption.
- •d)Large abdominal scars, tattoos, excessive hair in the application area.
- •e)The subject has a history of renal or hepatic dysfunction.
- •f)Relevant cardiovascular disorders, e.g. coronary disease, heart insufficiency, hypertension (sitting blood pressure at screening >150/92 mmHg), tachyarrhythmia.
- •g)The subject has a bladder obstruction, e.g. prostate hyperplasia, urethral strictures.
- •h)History or evidence of stenose of urinary or gastrointestinal tract; toxic megacolon, ileus, hiatus hernia, reflux oesophagitis, colon ulcera, intestinal atonia.
- •i)History or evidence of glaucoma (as screened by an ophthalmologist with an intraocular pressure >22mmHg in either eye).
- •j)History of cerebral sclerosis; myasthenia, autonomous neuropathy.
- •k)Hypersensitivity to drugs, atopic eczema or allergic bronchial asthma.
- •l)Clinically significant laboratory test results outside the reference values as laid down by the study centre, which may be an evidence of disease. Positive result of HIV1/2, HCV antibody or HBs antigen testing.
- •m)Regular use of any medication (except for hormonal contraception) within four weeks prior to commencement of the study (self-medication or prescription).
- •n)Single use of any medication (including OTC) that are not expressively permitted within two weeks prior to start of the study.
- •o)Abuse of alcohol (equivalent to more than 35 g ethanol per day) or caffeine (equivalent to more than 750 mg per day) or tobacco (equivalent to more than 10 cigarettes a day).
- •p)Drug addiction, positive drug screening in urine.
- •q)Participation in a clinical investigation or blood donation of more than 250 ml within the past eight weeks or blood donation of less than 250 ml within the past 4 weeks.
- •r)Subjects who are known or suspected
- •not to comply with the study directives
- •not to be reliable or trustworthy
- •not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed
- •to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in.
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