ISRCTN73285902已完成1 期
A Randomised, Double-Blind, Placebo-Controlled, Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Application of a Transdermal Patch Formulation of Hyoscine and Physostigmine in Healthy Male Subjects with Pigmented Skin of Grade 5 on the Fitzpatrick Skin Scale
Defence Science Technology Laboratory (Dstl)0 个研究点目标入组 6 人开始时间: 2019年11月5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
- 6
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. Ability to give written informed consent prior to study participation
- •2. Healthy male subjects with pigmented skin of Grade 5 on the Fitzpatrick skin scale
- •3. Aged between 18 and 45 years (inclusive)
- •4. Body Mass Index (BMI) within the range of 21and 30 kg/m2
- •5. Vital signs within the following ranges:
- •5.1. Pulse rate 40-90 bpm
- •5.2. Systolic blood pressure 90- 150 mmHg
- •5.3. Diastolic blood pressure 50- 95 mmHg
- •6. Ability to communicate well with the Investigator and to comply with the requirements of the study
- •Baseline Period 2:
- •1. Successful completion of Period 1
- •2. Willingness to continue in 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 (sinus bradycardia and respiratory sinus arrhythmia are considered to be normal findings in healthy young adults)
- •4. Known or suspected hypersensitivity or idiosyncratic reaction related to any of the study products
- •5. Any history of contact dermatitis
- •6. A dibucaine number of less than 70
- •7. Skin disorders, broken skin, scars or tattoos that were extensive enough to obscure the patch application sites 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. History of asthma (within the previous 10 years), exercise induced bronchospasm or relevant seasonal bronchospasm
- •14. Lung function of less than 80% of predicted FEV1 and FVC values.
- •15. History or evidence of drug abuse (opiates, methadone, cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates)
- •16. Positive test for HIV, Hepatitis B or Hepatitis C
- •17. 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
- •18. Positive urine test for alcohol
- •19. Participation in another clinical study within the previous three months
- •20. Use of any prescription medication within the previous 14 days
- •21. Use of non-prescription medication within the previous seven days (apart from paracetamol)
- •22. Donation of blood or blood products within the previous three months, or the intention to donate blood or blood products within three months after completion of the study
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