Sialorrhoea (chronic pathological drooling)
Conditions
Interventions
Trade Name: Cuvposa
Pharmaceutical Form: Oral solution
Product Name: Glycopyrronium Bromide Oral Solution (2 mg/5 ml)
Pharmaceutical Form: Oral solution
Sponsors
Proveca Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers: • Age: = 18 to = 50 years • Sex: Male or female • Status: Healthy volunteers with a body mass index of =20, =30kg/m2 • Subjects who give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Known allergy to glycopyrronium bromide or any of the excipients. • Refusal to give informed consent • Pregnancy • Use of glycopyrronium bromide liquid within approximately 24 hours prior to baseline • Use of any of the prohibited anticholinergic or cholinergic medications specified in the protocol within three plasma half-lives of the medication prior to baseline • Medical conditions contraindicating anticholinergic therapy including: Glaucoma, obstructive uropathy, uretovesicular reflux, reactive airway disease, myasthenia gravis, hyperthyroidism, cardiac arrhythmias and/or tachycardia, and/or clinically significant ECG abnormalities as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine and compare the pharmacokinetics (primary variables; AUC0-t, AUC¬0-8,, Cmax, tmax and t1/2) from the new oral solution of glycopyrronium bromide with glycopyrronium bromide from Cuvposa®. ;Secondary Objective: Evaluate the taste acceptability including sweet or bitter-tasting, granular or smooth in texture and of pleasant or unpleasant flavour of glycopyrronium bromide oral solution. Evaluate adverse events ;Primary end point(s): To determine and compare the pharmacokinetics (primary variables; AUC0-t, AUC¬0-8,, Cmax, tmax and t1/2) from the new oral solution of glycopyrronium bromide with glycopyrronium bromide from Cuvposa®. ;Timepoint(s) of evaluation of this end point: Potential participants will be screened and eligible subjects scheduled to commence treatment visits within 2 weeks of screening. Subjects to be randomised to one of two sequence (R-T or T-R), with 7 days between doses (R=Reference, T=Test). Dosing to take place in the morning after admission, with venous blood samples being drawn pre-dose and at 5, 10, 20, 30, 45, 60 minutes post-dose and 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate the taste acceptability including sweet or bitter-tasting, granular or smooth in texture and of pleasant or unpleasant flavour of glycopyrronium bromide oral solution. Evaluate adverse events ;Timepoint(s) of evaluation of this end point: Taste acceptability endpoint: assessed on the day of dosing. Adverse events: monitored for the duration of the trial. | — |
Countries
South Africa
Contacts
Public ContactDr. Helen Shaw
Proveca Ltd
Outcome results
None listed