ISRCTN78730348已完成1 期
A randomised, double-blind, placebo-controlled, crossover, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of physostigmine salicylate and hyoscine hydrobromide by continuous, intravenous infusion to healthy Caucasian male and female volunteers, given separately and in combination.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
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. Parts A and B: caucasian man. Part C: caucasian woman. Women of childbearing potential agreed to use adequate contraception and had a negative serum pregnancy test at screening and before each dose of Investigational Medicinal Product (IMP). Women were considered to be of non-childbearing potential if they were surgically sterile (had undergone removal of both ovaries and/or uterus, or had undergone bilateral tubal ligation at least 6 months before the trial).
- •2. Aged 18–40 years
- •3. Body mass index (BMI) in the range 18.9–29.0
- •4. Weight =60 kg
- •5. Normal vision (spherical error between +1.00 D and –1.00 D, and cylindrical error less than or equal to 1.00 D)
- •6. Part B, C: normal intraocular pressure and anterior chamber angle assessment
- •7. Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
- •8. Willingness to give written consent to participate after reading the Informed Consent Form, and having had the opportunity to discuss the trial with the investigator or his delegate
- •9. Willingness to give written consent to have data entered into The Overvolunteering Prevention System
排除标准
- •1. Pregnant or lactating
- •2. Pre-menopausal, sexually active, and not using a reliable method of contraception
- •3. Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could have interfered with the objectives of the trial or the safety of the volunteer
- •4. Presence of acute or chronic illness or history of chronic illness sufficient to have invalidated the volunteer’s participation in the trial or have made it unnecessarily hazardous
- •5. Impaired endocrine, thyroid, hepatic, respiratory, or renal function (including mechanical obstruction of the urinary system), diabetes mellitus, coronary heart disease or arrhythmias, or history of any psychotic mental illness
- •6. Current or past history of asthma (within the last 10 years)
- •7. History or family history of glaucoma
- •8. Dibucaine number <70
- •9. Presence or history of severe adverse reaction to any drug
- •10. Use of a prescription medicine (except hormonal contraceptives in females) during the 28 days before the first dose of IMP or use of a non-prescription medicine (including herbal supplements), with the exception of paracetamol (=2000 mg/day), during the 7 days before the first dose of IMP
- •11. Consumption of food and drink containing grapefruit (or grapefruit-related citrus fruit, such as Seville oranges and pomelos) during the 7 days before the first dose of IMP
- •12. Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months
- •13. Parts A-3 and B2-2 only: have received the same IMP in a previous part of this trial. Subjects who had previously taken physostigmine in Part A, could do Part B2-2 only, and subjects who had previously taken hyoscine in Part B1 or B2, could do Part A-3 only
- •14. Parts A-1, A-2, B1, B2-1, and C: participation in a previous part of this trial
- •15. Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly (for men) or 14 units of alcohol weekly (for women)
- •16. Use of tobacco or nicotine-containing products during the 6 months before the first dose of IMP
- •17. Blood pressure and heart rate in a seated position at the screening examination outside the ranges 90–140 mmHg systolic, 40–90 mmHg diastolic; heart rate 40-100 beats/min
- •18. QTcB interval >450 msec at screening (an average of 3 readings after 10 min rest)
- •19. Possibility that the volunteer would not cooperate with the requirements of the protocol
- •20. Evidence of drug abuse on urine testing
- •21. Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 1 or 2
- •22. Loss of more than 450 ml blood during the 3 months before the trial, e.g. as a blood donor
- •23. Objection by General Practitioner to volunteer entering trial
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