ISRCTN13607674已完成2 期
An investigation of the effects of an armband applied over the F11/21 physostigmine and hyoscine transdermal patch on pharmacokinetic, pharmacodynamic and safety profiles in healthy male subjects
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
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 Caucasian male subjects aged between 18 and 40 years (inclusive)
- •3. Body Mass Index (BMI) within the range of =21 and =29 kg/m²
- •4. Vital signs within the following ranges:
- •4.1. Heart 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 significantly alter 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 considered to be clinically significant i.e. baseline prolongation of QT/QTc interval >450 ms or history of additional risk factors for Torsade de Point (heart failure, hypokalemia, family history of Long QT Syndrome)
- •4. Known or suspected hypersensitivity or idiosyncratic reaction to any of the study products
- •5. A dibucaine number of less than 70
- •6. History of asthma (within the previous 10 years), exercise induced bronchospasm or relevant seasonal bronchospasm
- •7. Lung function of less than 80% of predicted FEV1 and FVC
- •8. Any history of contact dermatitis
- •9. Any skin disorder, broken skin, scars, tattoos at the sites of patch application (i.e. on both arms)
- •10. Glaucoma or a history of glaucoma in first-degree relatives (i.e. parents, siblings or offspring)
- •11. Presence of Anterior Chamber Narrow Angle (Van Herrick Grade 1 and 2)
- •12. Intra-ocular pressure exceeding 20 mmHg
- •13. Uncorrected vision in both eyes of worse than 6/9 on the Snellen Scale
- •14. Corrected vision of 6/9 or better on the Snellen Scale when wearing +2.25 dioptre reading glasses
- •15. Required glasses or contact lenses for distance vision
- •16. History or evidence of drug abuse (opiates, methadone, cocaine, amphetamines, cannabinoids or 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 the last three months
- •21. Use of any prescription medication within the last 14 days
- •22. Use of non-prescription medication (apart from paracetamol) within the last seven days that may have an impact on the safety and objectives of the study (at the Investigator’s discretion)
- •23. Donation of blood or blood products within the last three months, or the intention to donate blood or blood products within three months after completion of the study
- •Baseline (all periods):
- •1. Development of any exclusion criteria since last visit
- •2. Positive urine test for alcohol
- •3. Positive drugs of abuse test
- •4. Use of any prescription medication since last visit (with the exception of hormonal contraception)
- •5. Use of non-prescription medication that may impact the safety aspects and objectives of the study, within the last seven days (apart from paracetamol)
研究者
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