A two-staged, open label, single dose, two period, two-sequence,crossover study to compare the bioavailability of 2 mg GlycopyrroniumBromide from a new oral solution (2 mg/5 ml) (Test Product) with thatof 2 mg Glycopyrronium Bromide from Cuvposa (1 mg/5 ml) Solution(Reference product) in at least 36 healthy male and female subjectsunder fasting conditions.
- Conditions
- Sialorrhoea (chronic pathological drooling)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-002557-30-Outside-EU/EEA
- Lead Sponsor
- Proveca Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 36
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
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method