ISRCTN21827000已完成1 期
A randomised, double-blind, three-way crossover study to investigate the pharmacokinetics, pharmacodynamics, safety and tolerability after single applications of three transdermal patch formulations of physostigmine and hyoscine in healthy males
Dstl0 个研究点目标入组 18 人开始时间: 2019年7月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Healthy male participants
- •2. Aged between 18 and 40 years inclusive
- •3. Body Mass Index (BMI) = 18 and = 31 kg/m2, and body weight = 60 and = 110 kg
- •4. Able to understand the informed consent discussion, which included information about potential risks and effects of the test materials, and signed the informed consent form
- •5. Medical history without major pathology (e.g. cardiac, immunological, endocrine or neurological disorders, cancer or other wasting diseases)
- •6. Human immunodeficiency virus (HIV), hepatitis B and hepatitis C negative
- •7. No clinically significant abnormalities at the pre-study screening, and subject’s GP had not advised against inclusion
- •8. Computerised 12-lead ECG recording without clinically relevant signs of pathology and conductance disturbances as judged by the investigator
排除标准
- •1. Presence of any clinically significant medical condition as determined by the investigator
- •2. Known or suspected hypersensitivity or idiosyncratic reaction related to any of the test materials
- •3. Homozygous or heterozygous for the atypical (dibucaine resistant) allele of butyrylcholinesterase
- •4. Any skin disorder, broken skin, scars, tattoos at the site of application
- •5. Glaucoma or a history of glaucoma in first degree relatives (i.e. parents, siblings and offspring)
- •6. Presence of Anterior Chamber Narrow Angle (Van Herrick Grade 1 and 2)
- •7. Intra-ocular pressure exceeding 20 mm Hg
- •8. Uncorrected vision (or contact lens corrected vision) in either eye worse than 6/9 on the Snellen scale
- •9. History or evidence of drug abuse (including opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates)
- •10. History or evidence of alcohol abuse defined as intake of more than 21 units per week (3 units per day), where 1 unit corresponds to 250 mL beer, 20 mL spirits/liqueur or one glass (100 mL) of wine
- •11. Participation in another clinical trial within three months prior to the start of the study
- •12. Use of any prescription medication within two weeks, or non-prescription medication (e.g. acetylsalicylic acid/paracetamol) within 48 hours, prior to dosing
- •13. Regular drug intake during the month prior to the start of the study
- •14. History or suspicion of inability to co-operate adequately
- •15. Donation of blood or blood products for a period of four weeks prior to and four weeks after completion of the study
- •16. History of asthma (or history of asthma within the previous 10 to 15 years, at investigator’s discretion)
- •17. History of exercise-induced bronchospasm, or relevant seasonal bronchospasm
- •18. Lung function (FEV1) less than 80% of predicted spirometry criteria
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