ISRCTN10362655已完成1 期
An open, replicate, two-period, single and multiple-dose, pharmacokinetic and tolerability study of the PHP (150 g/m2) transdermal patch containing physostigmine and hyoscine in healthy, adult Caucasian males.
Dstl0 个研究点目标入组 35 人开始时间: 2019年3月7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
- 35
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. Able to give written informed consent prior to study participation
- •2. Healthy Caucasian male participants aged 18-40 years (inclusive).
- •3. Body mass index (BMI) within the range of =19 and =30 kg/m2.
- •4. Supine vital signs with no clinically significant deviations outside 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. Agreement not to attempt to father a child during the study or for 3 months after treatment. Participants with a partner who could become pregnant must have agreed to use a reliable form of contraception during the trial and for 3 months afterwards, e.g. condom, established use of oral, injected or implanted hormonal contraceptive, intra-uterine device, diaphragm with spermicide.
- •6. Able 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 considered to be clinically significant i.e. prolongation of QT/QTc interval >450 msec or history of additional risk factors for Torsades 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. History of asthma (within the previous 10 years), exercise-induced bronchospasm or relevant seasonal bronchospasm
- •6. Lung function of less than 80% of predicted forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)
- •7. Any history of contact dermatitis
- •8. Any skin disorder, broken skin, scars, tattoos at the sites of patch application (i.e. on both upper arms)
- •9. Glaucoma or a history of glaucoma in first-degree relatives (i.e. parents, siblings or offspring)
- •10. Presence of anterior chamber narrow angle (Van Herrick Grade 1 and 2)
- •11. Intraocular pressure exceeding 20 mmHg
- •12. Contact lens wearer
- •13. History or evidence of drug abuse (opiates, methadone, cocaine, amphetamines, cannabinoids or barbiturates)
- •14. Positive urine test for alcohol (test could have been repeated at baseline (Day -1 and Day 0), at the Investigator’s discretion)
- •15. History or evidence of alcohol abuse defined as an intake of more than 28 units per week where 1 unit corresponds to 250 ml beer, 20 ml spirits/liqueur or 100 ml of wine
- •16. Participation in a new chemical entity (NCE) clinical study within the last 4 months or a marketed drug clinical study within the previous 3 months. (N.B. Washout period between studies defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study.)
- •17. Use of any prescription medication within the last 14 days
- •18. Use of non-prescription medication (apart from paracetamol and ibuprofen) within the last 7 days that may have impacted on the safety and objectives of the study (at the Investigator’s discretion)
- •19.Donation of blood or blood products within the last 3 months, or the intention to donate blood or blood products within 3 months after completion of the study
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