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This will be an open-label, randomised, 2-treatment period, single-dose crossover study to determine the comparative bioavailability and renal elimination following single-dose administration of 3.0 mg cytisine in healthy smokers under fed and fasted conditions.
Enrollment
Sex
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Volunteers
Inclusion criteria
To be Confirmed at Screening
Subject is current cigarette smoker.
Healthy males and females between 18 and 55 years of age.
Subject with a body mass index (BMI) of 23-28 kg/m^2. BMI = body weight in kg / [height in m^2].
Subject with no clinically significant abnormal serum biochemistry or haematology values within 28 days before the first dose of cytisine.
Subject with negative urinary drugs of abuse screen, determined within 28 days before the first dose of cytisine (a positive result may be repeated at Investigator's discretion).
Subject with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
Subject with no clinically significant abnormalities in 12-lead ECG determined after minimum of 5 minutes in supine position within 28 days before the first dose of cytisine.
Subject with no clinically significant abnormalities in vital signs (systolic blood pressure between 90-140 mmHg, diastolic blood pressure (DBP) between 50 and 90 mmHg, and pulse rate (PR) between 40-100 bpm, measured on the dominant arm after minimum of 5 minutes in supine position) determined within 28 days before first dose of cytisine.
Subject must be available to complete the study (including post study follow-up) and comply with study restrictions.
Subject must provide written informed consent to participate in the study.
To be Re-Confirmed Prior to Dosing
Exclusion criteria
To be Confirmed at Screening
To be Re-Confirmed Prior to Dosing:
Primary purpose
Allocation
Interventional model
Masking
13 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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