Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
NCT ID:
NCT02548806
Eligibility 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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02548806
Study Brief:
Protocol Section:
NCT02548806