Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers

Main Inclusion Criteria: * Healthy males or females (non-pregnant/non-lactating) aged 18 - 50 years. * A Body Mass Index (BMI) of 18-30. * No clinically significant abnormal serum biochemistry, haematology and urine examination values. * A negative urinary drugs of abuse screen. * Negative HIV and Hepatitis B and C results. * No clinically significant abnormalities in 12-lead electrocardiogram (ECG). * No clinically significant abnormalities in blood pressure or pulse. * No allergy or sensitivity to clonidine or any of its excipients. * No allergy to milk or milk derivatives. * Subjects must provide written informed consent to participate in the study Main Exclusion Criteria: * Current or past medical condition that might significantly affect the pharmacokinetic or * pharmacodynamic response to clonidine. * Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the previous 30 days. * Pathological condition of the oral cavity that would affect administration via the buccal route. * Raynaud's disease or other peripheral vascular disease. * Receipt of regular medication within 14 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion). * Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction. * Symptomatic postural hypotension evident on screening * History or evidence of Suicidal Ideation and/or behaviour as determined by using Columbia-Suicide Severity Rating Scale (C-SSRS)