Pharmacokinetic Study of 4 mg Nicotine Lozenge.

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Smoking Cessation

Clinical Trial Details

NCT number	NCT01669122
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 2
Start date	June 2012
Completion date	August 2012

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