At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 200 enrolled
Drug / intervention
Nicotine +1 moredrug
Likely dose
Not stated in 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 Randomized, Open Label Study to Evaluate the Oral Tolerability of a Nicotine Prototype
In Brief
A Phase 1 clinical trial evaluating Nicotine for Healthy Volunteer Smokers. Completed, enrolled 200 participants.
Detailed Summary
This study is to evaluate the oral tolerability of a nicotine prototype
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer Smokers
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedMay 2008
Primary CompletionJan 2009
TodayJul 2026
First PostedMay 22, 2008
Enrollment StartSep 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.1 years ago
Interventions
Nicotinedrug
Marketed nicotine replacement therapy formulation
Nicotinedrug
Nicotine prototype