Phase 2
Completed N=40
Pharmacokinetic Study of 4 mg Nicotine Lozenge.
Source: ClinicalTrials.gov NCT01669122 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Area Under the Curve From Time 0 to t, AUC (0-t) — 89.14; 87.38; 86.60; 91.97 nanograms (ng)*hours (h)/milliliter (mL)
Summary
This is a randomized, single center, open label, single dose, four way crossover study in fasted healthy male subjects to compare the pharmacokinetics of nicotine following administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge. Blood samples will be drawn at pre-specified intervals for a total of 12 hours post dose in each treatment session and plasma samples analyzed for nicotine levels.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time 0 to t, AUC (0-t) |
89.14; 87.38; 86.60; 91.97 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) |
18.50; 18.39; 17.41; 18.97 | — |
| SECONDARY AUC(0-inf) |
100.33; 98.90; 97.83; 104.53 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) |
1.50; 1.50; 1.50; 1.50 | 0.2208 |
| SECONDARY Rate of Elimination (Kel) |
0.26; 0.26; 0.27; 0.26 | — |
| SECONDARY Plasma Half Life (t1/2) |
2.86; 2.91; 2.86; 2.94 | — |
Eligibility Criteria
Inclusion Criteria
- smoked commercially-manufactured cigarettes daily for the preceding 12 months and routinely smokes first cigarette within 30mins of awakening.
Exclusion Criteria
- inability to refrain from smoking during confinement period, smoking tobacco in any other form other than commercially manufactured cigarettes, subject has used chewing tobacco or other tobacco products other than commercially manufactured cigarettes within 7 days of dosing
Data sourced from ClinicalTrials.gov (NCT01669122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.