Pharmacokinetics and Safety of Rivastigmine Nasal Spray versus Exelon (Registered Trademark) Capsule in Healthy Men

INTERVENTION: Treatment A: Rivastigmine Nasal Spray 4mg as single dose (One spray each nostril) Treatment B: Exelon (Registered Trademark) 3mg oral capsule as single dose Participants randomised to receive each treatment as a crossover with a single dose given on the first day, followed by a 2‐day washout and a single dose given on the fourth day. Treatments administered by site staff to participants under direct supervision. CONDITION: Alzheimer's disease; ; Alzheimer's disease Neurological ‐ Alzheimer's disease PRIMARY OUTCOME: Pharmacokinetics: Cmax, tmax, AUC0‐last, AUC0‐infinity, t1/2 and terminal elimination rate constant,; ; Plasma assay for rivastigmine and its' primary metabolite (NAP 226‐90) and pharmacokinetic parameters calculated using noncompartmental pharmacokinetic analysis. Inferential statistics on the natural log‐transformed (ln) pharmacokinetic parameters (Cmax, AUC0‐last, AUC0‐infinity) will be performed using the 3mg oral dose as reference. [Nasal: Pre‐dose, 5, 10, 15, 30, 45, 60, 90 mins; 2, 3, 4, 6, 8, 10, 12 and 24 h; Oral: Pre‐dose, 15, 30, 45, 60, 90 mins; 2, 3, 4, 6, 8, 10, 12, 15 and 24 h] SECONDARY OUTCOME: Safety: Adverse events reporting, visual nasal mucosal examination and healthy screen pre‐ and poststudy. ; ; Healthy screen includes: Physical examination, including vital signs (blood pressure, heart rate, respiratory rate and temperature) and ECG. Urinalysis for general health (urine pH, blood, protein, ketones, leukocyte elastase, nitrates, glucose, Specific gravity, urobilinogen and bilirubin) and any drugs of addiction*. Blood collected for clinical laboratory analysis (serum chemistry and haematology) and analysis for HIV*, hepatitis B*, and hepatitis C* analysis. Normal ranges for clinical laboratory parameters will be as per the local laboratory definitions. ; *Pre‐study[Visual nasal mucosal examination at screening, check‐in, pre‐nasal‐dose and 24 hours postnasal‐dose. ; Adverse events are monitored from Day 1 until Day 5 (24 hours post‐dose) and at follow‐up visit (Day 9 +/‐ 1). ; Healthy screens are undertaken at screening, admission (Day ‐1) and on Day 5 (24 hours post‐dose).] INCLUSION CRITERIA: ‐ 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).