At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 22 enrolled
Drug / intervention
Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg +1 moredrug
Likely dose
Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 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.
Open-Label, Single-Center, Randomized, 2-way Crossover Study Evaluating Relative Bioavailability of OC-01 (Varenicline) Nasal Spray as Compared to Orally Administered Varenicline (the Zen Study)
In Brief
A Phase 1 clinical trial evaluating Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg and OC-01 (varenicline solution) nasal spray 0.12 mg then Varenicline oral tablet 1 mg for Healthy Subjects. Completed, enrolled 22 participants across 1 site.
Detailed Summary
To assess the relative bioavailability of varenicline administered intranasally at its highest intended clinical strength compared to varenicline administered orally at its highest oral tablet strength.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
Enrollment StartAug 2019
First PostedAug 2019
Primary CompletionNov 2019
TodayJul 2026
First PostedAug 28, 2019
Enrollment StartAug 26, 2019
Primary CompletionNov 15, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.8 years ago
Interventions
Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mgdrug
Cross over bioavailability study
OC-01 (varenicline solution) nasal spray 0.12 mg then Varenicline oral tablet 1 mgdrug
Cross over bioavailability study