ACTRN12618001817235招募中1 期
Pharmacokinetics of atropine after sublingual and oral administration in healthy and clozapine-treated adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •Healthy Participants:
- •1.Age: between 18 and 50 year old
- •2.Non pregnant or breast feeding
- •3.Able to consent for participation in the study
- •4. Healthy as per the pathology test results, ECG, and medical history.
- •Clozapine-treated patients:
- •1.Age: between 18 and 50 year old
- •2.Non pregnant or breast feeding
- •3.Able to consent for participation in the study
- •4. Treated with clozapine.
排除标准
- •Healthy Participants:
- •1.Known allergy to atropine
- •2.Over the last 3 months found to have a serum bilirubin, albumin, or INR outside the normal range.
- •3.Over the last 3 months found to have an eGFR less than 90mL/min/1.73m2
- •4.Known to have or found upon screening to have high blood pressure ( more than 140/90), postural hypotension, angina, or cardiac arrhythmia.
- •5.Known to have glaucoma, myasthenia gravis, prostatic hypertrophy, bladder obstruction, GI obstructive disease such as ileus, or other medical illness that may be seriously adversely affected by atropine, tachycardia secondary to cardiac insufficiency or thyrotoxicosis, fever, or pregnancy induced hypertension.
- •6.Have dry mouth, hypersalivation or drooling.
- •7.Treated with an anticoagulants, antiarrhythmics, depolarising and non-depolarising muscle relaxants, or neuromuscular blocking agents.
- •8.Treated with a medication that has an anticholinergic effects such as: olanzapine, quetiapine, chlorpromazine, hyoscine, benztropine, ipratropium bromide, oxybutynin, solifenacin, darifenacin, sedating antihistamines such as promethazine, benzhexol, tricyclic or tetracyclic antidepressants. Inhalation medications with anticholinergic effect are exempted.
- •9.Treated with a medication with a cholinergic effect such as Anticholinesterases used in the treatment of dementia such as donepezil.
- •Clozapine treated participants:
- •Known to have any of the following conditions:
- •1. Known allergy to atropine
- •2. Females during the menstrual period
- •3. Over the last 3 months found to have a serum bilirubin, albumin, or INR outside the normal range.
- •4. Over the last 3 months found to have an eGFR less than 90mL/min/1.73m2
- •5. Known to have or found upon screening to have high blood pressure (more than 140/90), postural hypotension, angina, or cardiac arrhythmia.
- •6. Known to have glaucoma, myasthenia gravis, prostatic hypertrophy, bladder obstruction, GI obstructive disease such as ileus, or other medical illness that may be seriously adversely affected by atropine, tachycardia secondary to cardiac insufficiency or thyrotoxicosis, fever, or pregnancy induced hypertension.
- •7. Have severe constipation or diarrhoea.
- •8. Have dry mouth, hypersalivation or drooling.
- •9. Wearing dental braces
- •10. Treated with an anticoagulants, antiarrhythmics, depolarising and non-depolarising muscle relaxants, or neuromuscular blocking agents.
- •11. Is treated with any medication other than clozapine that is known to have a significant anticholinergic effects such as: olanzapine, quetiapine, chlorpromazine, hyoscine, benztropine, ipratropium bromide, oxybutynin, solifenacin, darifenacin, sedating antihistamines such as promethazine, benzhexol, tricyclic or tetracyclic antidepressants. Inhalation medications with anticholinergic effect are exempted.
- •12. Treated with a medication with a cholinergic effect such as Anticholinesterases used in the treatment of dementia such as donepezil.
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