ISRCTN29062676已完成1 期
A Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Four Transdermal Patch Formulations (F4-F7) of Hyoscine and Physostigmine in Healthy Male Subjects
Defence Science and Technology Laboratory (Dstl)0 个研究点目标入组 24 人开始时间: 2019年9月6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
- 24
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
- •Subjects had to meet all of the following criteria:
- •1. Ability to give written informed consent prior to study participation
- •2. Healthy Caucasian male subjects aged between 18 and 40 years (inclusive)
- •3. Body Mass Index (BMI) within the range of ? 21 and ? 30 kg/m2
- •4. Vital signs within the following ranges:
- •4.1 Pulse rate 40-90 bpm
- •4.2 Systolic blood pressure 90-140 mmHg
- •4.3 Diastolic blood pressure 50-90 mmHg
- •5. Ability to communicate well with the Investigator and to comply with the requirements of the study
排除标准
- •1. Presence of any clinically significant medical condition as determined by the Investigator
- •2. Any surgical or medical condition which might have significantly altered the absorption, distribution, metabolism or excretion of any drug. (e.g. renal or liver disease, respiratory, immunological, endocrine or neurological disorders)
- •3. Any ECG abnormality other than sinus bradycardia or respiratory sinus arrhythmia
- •4. Known or suspected hypersensitivity or idiosyncratic reaction related to any of the study products
- •5. Any history of contact dermatitis
- •6. Plasma cholinesterase genotype homozygous for A or S variant
- •7. Any skin disorder, broken skin, scars, tattoos at the sites of patch application (i.e. on both arms)
- •8. Glaucoma or a history of glaucoma in first degree relatives (i.e. parents, siblings or offspring)
- •9. Presence of Anterior Chamber Narrow Angle (Van Herrick Grade 1 and 2)
- •10. Intra-ocular pressure exceeding 20 mm Hg
- •11. Uncorrected vision in both eyes of worse than 6/9 on the Snellen Scale
- •12. Required glasses or contact lenses for distance vision
- •13. Peripheral visual fields outside of age corrected normal parameters
- •14. History of asthma (within the previous 10 years), exercise induced bronchospasm or relevant seasonal bronchospasm
- •15. Lung function of less than 80% of predicted spirometry criteria
- •16. History or evidence of drug abuse (opiates, methadone, cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates)
- •17. Positive test for HIV, hepatitis B or hepatitis C
- •18. History or evidence of alcohol abuse defined as an intake of more than 28 units per week (4 units per day), where 1 unit corresponds to 250 ml beer, 20 ml spirits/liqueur or one glass (100 ml) of wine
- •19. Positive urine test for alcohol
- •20. Participation in another clinical study within three months prior to Screening
- •21. Use of any prescription medication within 21 days prior to Baseline
- •22. Use of non-prescription medication within 7 days prior to Baseline (apart from paracetamol)
- •23. Donation of blood or blood products for a period of 3 months prior to or the intention to donate blood or blood products within 3 months after completion of the study
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