None listed
Conditions
Brief summary
A few medications were reported to be better absorbed into the systemic blood circulation after administration under the tongue. In this study, the absorption of atropine into the blood circulation was measured after atropine solution administration under the tongue solution and oral administration. The extent of absorption of atropine after 0.6mg and 1.2mg dose administration of under the tongue atropine was also measured.
Interventions
The study will involve the administration of 0.6mg atropine sulfate solution under the tongue (sublingual) on day 1, 0.6mg atropine sulfate oral (swallowed) tablet at least 4 days after day 1, then 1.2mg atropine sulfate solution under the tongue at least 4 days after day 2.
All participants will have the study medications at this sequence of administration.
The extent and rate of atropine sulfate absorption after sublingual administration will be compared to that after the tablet oral admini
The study will involve the administration of 0.6mg atropine sulfate solution under the tongue (sublingual) on day 1, 0.6mg atropine sulfate oral (swallowed) tablet at least 4 days after day 1, then 1.2mg atropine sulfate solution under the tongue at least 4 days after day 2. All participants will have the study medications at this sequence of administration. The extent and rate of atropine sulfate absorption after sublingual administration will be compared to that after the tablet oral administration. The study will involve the administration of each dose once only. Participants will be observed over the first one hour after the medication administration. Participants will be remaining in the Charles Perkins Unit clinics area over the study period (10 hours) on each of the study days.
Sponsors
Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed