N/A
Completed N=45
Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
Source: ClinicalTrials.gov NCT01084603 ↗Enrolled (actual)
45
Serious AEs
0.5%
Results posted
Jul 2010
Primary outcomePrimary: Maximum Plasma Concentration — 3.04; 4.94; 8.63; 6.44 (ng/ml)
Summary
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration |
3.04; 4.94; 8.63; 6.44; 7.36 | — |
| PRIMARY Bioavailability |
5.85; 11.50; 21.96; 22.00; 19.69; 7.54 | — |
| SECONDARY Nicotine Plasma Concentration |
0.43; 0.56; 0.87; 0.29; 0.29 | — |
| SECONDARY Time of Maximum Concentration |
0.17; 0.21; 0.17; 0.75; 0.50 | — |
| SECONDARY Terminal Elimination Rate Constant |
0.29; 0.29; 0.30; 0.26; 0.31 | — |
| SECONDARY Released Nicotine |
2.70 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy smokers, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
- Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
- A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
Exclusion Criteria
- Pregnancy, lactation or intended pregnancy.
- Treatment with an investigational product or donation or loss of blood within 3 months preceding the first dose of study medication.
Data sourced from ClinicalTrials.gov (NCT01084603). 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.