At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Cytisinedrug
Likely dose
Cytisine 1.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Open Label, Randomized, Two-Way Crossover Study in Healthy Volunteers to Investigate the Effect of Food on the Bioavailability of Cytisine
In Brief
A Phase 1 clinical trial evaluating Cytisine for Smoking Cessation. Completed, enrolled 24 participants across 1 site.
Detailed Summary
This will be an open-label, randomised, 2-period, single-dose crossover study to determine the comparative bioavailability of cytisine following single-dose administration in healthy male and female subjects under fed and fasted conditions. The study will be comprised of a pre-study screen, followed by 2 treatment periods (1 and 2) and a post-study follow-up.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartAug 2017
Primary CompletionAug 2017
First PostedAug 2017
Study CompletionSep 2017
TodayJul 2026
First PostedAug 31, 2017
Enrollment StartAug 8, 2017
Primary CompletionAug 26, 2017
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 18 daysPosted 8.8 years ago
Interventions
Cytisinedrug
Cytisine 1.5 mg Film-Coated Tablets