ISRCTN62968791已完成1 期
A double-blind investigation of the effects of daily applications of the physostigmine and hyoscine transdermal patch (NAPS2 F11/21) with an armband on the pharmacokinetic (PK), pharmacodynamic (PD) and safety profiles over a 21-day period in healthy male and female Caucasian subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
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
- All
入选标准
- •1. Ability to give written informed consent prior to study participation
- •2. Healthy Caucasian male and female subjects aged between 18 and 40 years (inclusive)
- •3. Female subjects enrolled provided she:
- •3.1. Had a negative pregnancy test prior to entry into the study and:
- •3.2. Had a documented record of surgical sterilisation
- •3.3. Was of child-bearing potential and:
- •3.3.1. Agreed not to attempt to become pregnant during the study
- •3.3.2. Was routinely using an acceptable form of effective contraception (established use of oral, injected or implanted hormonal methods of contraception, intrauterine device (IUD) or intrauterine system (IUS), barrier method of contraception (condom or occlusive cap with spermicide), male sterilisation of sole partner; agreed to continue to do so during the study and for 28 days after study completion and agreed to use an additional barrier method for the duration of the study and for 28 days after study completion. (Hormonal contraception was not changed in the 3 months before the study).
- •3.3.3. Was not breastfeeding
- •4. Had a refractive error between -1 and +4 dioptres (D) spherical error and =1 D cylindrical error as measured by cycloplegic examination, habitually uncorrected
- •5. Had a spherical error between 1 D myopia and 4 D hyperopia.
- •6. Was able to read reduced Snellen type 6/9 at 35 cm (to exclude early presbyopia)
- •7. Had a best corrected visual acuity of 6/9 or better in each eye at 6 m
- •8. Had a near point stereopsis of 40 arc sec or better
- •9. Body Mass Index (BMI) within the range of =21 and =30 kg/m²
- •10. Vital signs with no clinically significant deviations outside the following ranges:
- •10.1. Heart rate 40-90 bpm
- •10.2. Systolic blood pressure 90-140 mmHg
- •10.3. Diastolic blood pressure 50-90 mmHg
- •11. Ability to communicate well with the Investigator and to comply with the requirements of the study (including contraception requirement)
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 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. 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 mm Hg
- •13. Habitual wearers of spectacles or contact lenses, although if they had been prescribed them in the past and did not use them, they could still be included
- •14. Astigmatism greater than 1 D cyl
- •15. History or evidence of drug abuse (opiates, methadone, cocaine, amphetamines, cannabinoids or 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 21 units (females) or 28 units (males) per week 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 last three months
- •20. Use of any prescription medication within the last 14 days (with the exception of hormonal contraception)
- •21. Use of non-prescription medication (apart from paracetamol and ibuprofen) within the last 7 days that could have an impact on the safety and objectives of the study (at the Investigator’s discretion).
- •22. 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.
- •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. Positive pregnancy test
- •5. Use of any prescription medication since last visit (with the exception of hormonal contraception)
- •6. Use of non-prescription medication that may impact the safety aspects and objectives of the study, within the last 7 days (apart from paracetamol and ibuprofen)
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