A Randomised, Crossover, Two Period, Pharmacokinetic, Bioavailability and Safety Study of a Single Dose of the Novel Rivastigmine Nasal Spray and Single Dose Rivastigmine (Exelon, Registered Trademark) Oral Capsule in Young Healthy Adult Males

achesis Biosciences Ltd0 个研究点目标入组 16 人开始时间: 2019年11月1日最近更新: 2020年4月27日

研究概览

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•Healthy males between 18 and 55 years (inclusive) of age.
•- No known history of clinically significant liver, neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, haematopoietic disease, neoplasm or any other clinically significant medical disorder, which in the Investigator's judgment contraindicate administration of the study interventions.
•- BMI 18-32 (inclusive) calculated as Weight (Kg)/Height (sq.m).

•- Known hypersensitivity to rivastigmine, components (benzyl alcohol, benzoates), other carbamates or ondansetron.
•- Current symptomatic allergic rhinitis.
•- Presence of significant disease or anatomical abnormality affecting the nasal passages.
•- History of or currently active asthma or chronic obstructive pulmonary disease, excluding childhood asthma.
•- Use of any prescription, OTC or herbal medication within 7 days or 5 half-lives (whichever is longer) of study drug administration, with the exception of the oral contraceptive pill, paracetamol up to 2g daily and low-moderate dose NSAID.
•- History of or currently active cardiac arrhythmias such as bradycardia and sick sinus syndrome.
•- History of heart block or disease of cardiac conducting system.
•- History of urinary tract obstruction.
•- History of or currently active GI diseases such as peptic ulcer, GERD, bleeding or history of any GI surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder likely to influence drug absorption, or with any history of anorexia, frequent nausea or emesis, regardless of aetiology.

发起方

achesis Biosciences Ltd