N/A
Completed N=84
Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab
Source: ClinicalTrials.gov NCT01238640 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) — 3.90; 4.00; 4.08 ng/mL
Summary
The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
3.90; 4.00; 4.08 | — |
| PRIMARY Area Under the Curve [AUC(0-t)] |
12.69; 12.56; 13.01 | — |
| PRIMARY AUC(0-∞) |
15.74; 15.09; 15.57 | — |
| SECONDARY Product Dissolution Time |
23.3; 23.8; 25.0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects, smoking at least 10 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 month preceding the first dose of study medication.
Data sourced from ClinicalTrials.gov (NCT01238640). 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.