ISRCTN15358284已完成1 期
A study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single application (one or two dose levels) and multiple applications (one dose level) of the transdermal patch formulations of physostigmine and hyoscine in healthy female subjects
Dstl0 个研究点目标入组 36 人开始时间: 2020年1月20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
- 36
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
- •Screening (all periods):
- •1. Ability to give written informed consent prior to study participation
- •2. Healthy Caucasian female subjects aged between 18 and 45 years (inclusive)
- •3. A female with a documented record of surgical sterilisation, or of child-bearing potential could be enrolled provided she:
- •3.1. Had a negative pregnancy test prior to entry into the study and agreed not to attempt to become pregnant during the study.
- •3.2. Is routinely using adequate hormonal contraception (including hormonal implants, depot injections, and hormone-impregnated IUDs when supplemented by a barrier method) which had not been changed in the three months before the study; agreed to continue to do so during the study, and agreed to use an additional barrier method for the duration of the study and for 28 days after study completion
- •3.3. Is not breastfeeding
- •4. Body Mass Index (BMI) within the range of =21 and =30 kg/m²
- •5. Individual vital signs must be within the following ranges:
- •5.1. Pulse rate 50-90 bpm
- •5.2. Systolic blood pressure 100-140 mmHg
- •5.3. Diastolic blood pressure 50-90 mmHg
- •6. Ability to communicate well with the investigator and comply with the requirements of the study
- •7. Subjects intending to take part in two study periods must agree not to take part in another clinical study involving blood sampling for a further 4 months (due to the relatively high amount of blood required for this study)
排除标准
- •Screening (all periods):
- •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 clinically-significant ECG abnormality other than sinus bradycardia or respiratory sinus arrhythmia
- •4. Evidence of postural hypotension (BP measurement after 5 minutes supine and again after 2 minutes standing, defined as a decrease between the two measurements of more than 20 mmHg (systolic)
- •5. Known or suspected hypersensitivity or idiosyncratic reaction related to any of the study products
- •6. Any history of contact dermatitis
- •7. A dibucaine number of less than 70
- •8. Any skin disorder, broken skin, scars, tattoos at the sites of patch application (i.e. on both arms, if volunteer planned to take part in more than one patch administration)
- •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. Intra-ocular pressure exceeding 20 mmHg
- •12. Uncorrected vision in either eye of worse than 6/9 on the Snellen Scale
- •13. Corrected vision of 6/9 or better on the Snellen Scale when wearing +2.25 dioptre reading glasses.
- •14. Require glasses or contact lenses for distance vision
- •15. History of asthma (within the previous 10 years), exercise induced bronchospasm or relevant seasonal bronchospasm
- •16. Lung function of less than 80% of predicted FEV1 and FVC values
- •17. History or evidence of drug abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates)
- •18. Positive test for HIV, Hepatitis B surface antigen or Hepatitis C antibody
- •19. History or evidence of alcohol abuse defined as an intake of more than 21 units per week (where 1 unit corresponds to 250 ml beer, 20 ml spirits/liqueur or one glass (100 ml) of wine)
- •20. Positive urine test for alcohol
- •21. Participation in another clinical study within the last three months
- •22. Use of any prescription medication within the last 14 days (with the exception of hormonal contraception)
- •23. Use of non-prescription medication that may have impacted the safety aspects and objectives of the study, within the last 7 days (apart from paracetamol)
- •24. 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 if taking part in one study period or donated blood or blood products within 4 months after completion of the study if taking part in two study periods
- •Baseline (all periods):
- •1. Evidence of postural hypotension (BP measurement after 5 minutes supine and again after 2 minutes standing, defined as a decrease between the two measurements of more than 20 mmHg (systolic)
- •2. Development of any exclusion criteria since last visit
- •3. Positive urine test for alcohol
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