NCT01228617

Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

Single-dose Pharmacokinetics of Oral Nicotine Replacement Products - An Exploratory Study in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Nicotine	Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day
DRUG	Nicotine Gum	Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes.

Timeline

• Start date: 2007-09-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2010-10-26
• Last updated: 2011-10-06

Locations

1 site across 1 country: Sweden