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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg and 100 μg Clonidine and comparative bioavailability of clonidine with that from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Onxeo
• Collaborator: Simbec Research
• Treatments: Clonidine

Criteria

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)