drugset / Trial / NCT01574898

Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations

NCT01574898 ↗

Phase 1 Completed 13 enrolled Pierre Fabre Laboratories
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to determine the pharmacokinetic profile of nicotine following a single oral administration of three new nicotine lozenge formulations (V0474) in comparison with two reference products. The clinical and biological safety of V0474 and the lozenge acceptability will also be assessed.

Timeline

Start
2012-03
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Niquitin® Fresh Mint Unknown 4 mg Oral
Subject V0474 Unknown — Oral
Comparator VANILLYL ALCOHOL Small molecule — Oral

Indications

No indication recorded.