Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

Status Completed

Clinical Trial Summary

This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.

Clinical Trial Description

This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Tobacco Dependence

Clinical Trial Details

NCT number	NCT01228617
Study type	Interventional
Source	Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status	Completed
Phase	N/A
Start date	September 2007
Completion date	October 2007

View Details

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