Phase 1
Completed N=40
A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
Source: ClinicalTrials.gov NCT01702519 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Area Under the Curve From Time 0 to the Last Quantifiable Sample, AUC(0-t) — 494.54; 528.43 nanogram (ng)*hour (hr)/milliliter (mL)
Summary
Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an alternative supplier delivers the same nicotine blood profile as that of the currently approved NTS with a polyisobutylene adhesive from the current supplier.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time 0 to the Last Quantifiable Sample, AUC(0-t) |
494.54; 528.43 | — |
| PRIMARY Maximum Measured Plasma Concentration (Cmax) |
22.31; 23.50 | — |
| SECONDARY Area Under the Concentration Time Curve Between Zero and Infinity, AUC (0-inf) |
505.13; 541.15 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) |
10.00; 17.99 | — |
| SECONDARY Plasma Half-life (t1/2) |
2.55; 2.59 | — |
| SECONDARY Rate of Elimination (Kel) |
0.27; 0.27 | — |
Eligibility Criteria
Inclusion Criteria
- BMI 19-27 kg/m2
- smokes >10 cigarettes per day for preceeding 6 months
Exclusion Criteria
- inability to stop smoking during study
Data sourced from ClinicalTrials.gov (NCT01702519). 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.