NCT01234896

Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products. A Study in Healthy Smokers.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.

Detailed description

Forty-four (44) healthy male or female subjects will be included. Single doses of an experimental Nicotine medicated chewing gum 6 mg and Nicorette® Freshfruit gum 4 mg and 2 mg and NiQuitin™ Mint lozenge 4 mg will be administered in a standardized mode, on four separate treatment visits. Periods without nicotine replacement therapy, each lasting for at least 36 hours, will separate the treatment visits. The subjects will abstain from smoking from 8 pm the evening before each treatment visit and until the end of each visit. Blood for pharmacokinetic analyses will be drawn before, and at 2, 4, 6, 8, 10, 15, 20, 30, 45, and 60 minutes as well as at 1.5, 2, 4, 6, 8, 10, and 12 hours after, product administration. Subjects will be monitored to capture any adverse events that may occur.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Nicotine Medicated Gum	Dosage Form: Gum; Dosage: 6 mg; Frequency: Once; Duration: 30 minutes
DRUG	4 mg Nicotine Gum	Dosage Form: Gum; Dosage: 4 mg; Frequency: Once; Duration: 30 minutes
DRUG	2 mg Nicotine Gum	Dosage Form: Gum; Dosage: 2 mg; Frequency: Once; Duration: 30 minutes
DRUG	4 mg Nicotine Lozenge	Dosage Form: Lozenge; Dosage: 4 mg; Frequency: Once; Duration: until dissolved

Timeline

• Start date: 2010-10-01
• Primary completion: 2010-11-01
• Completion: 2010-12-01
• First posted: 2010-11-04
• Last updated: 2012-07-10

Locations

1 site across 1 country: Sweden