At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 84 enrolled
Drug / intervention
Nicotine (2 mg) +1 moredrug
Likely dose
Nicotine (2 mg)from 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 Pharmacokinetic Study Comparing Two Nicotine Gum Formulations in a Single Dose Design
In Brief
A Phase 1 clinical trial evaluating Nicotine (2 mg) and Nicotine (4 mg) for Smoking Cessation. Completed, enrolled 84 participants across 1 site.
Detailed Summary
The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy smokers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2013
First PostedMay 2013
Primary CompletionJun 2013
TodayJul 2026
First PostedMay 6, 2013
Enrollment StartMay 1, 2013
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13.2 years ago
Interventions
Nicotine (2 mg)drug
2 mg nicotine gum in two formulations
Nicotine (4 mg)drug
4 mg nicotine gum in two formulations