Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

Tobacco Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234896
• Other study ID #: NICTDP1080
• Secondary ID: 2010-021087-15
• Status: Completed
• Phase: N/A
• First received: November 3, 2010
• Last updated: July 6, 2012
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kilograms per square meter and a total body weight of at least 55.0 kilograms.

• Female participants of child-bearing potential are required to use a medically acceptable means of birth control.

• A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

• Pregnancy, lactation or intended pregnancy.

• Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Study Design

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

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

Drug:
• Nicotine Medicated Gum
Dosage Form: Gum; Dosage: 6 mg; Frequency: Once; Duration: 30 minutes
• 4 mg Nicotine Gum
Dosage Form: Gum; Dosage: 4 mg; Frequency: Once; Duration: 30 minutes
• 2 mg Nicotine Gum
Dosage Form: Gum; Dosage: 2 mg; Frequency: Once; Duration: 30 minutes
• 4 mg Nicotine Lozenge
Dosage Form: Lozenge; Dosage: 4 mg; Frequency: Once; Duration: until dissolved

Locations

Country	Name	City	State
Sweden	McNeil AB Clinical Pharmacology R&D	Lund

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)	Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)	12 hours post-dose	No
Primary	Area Under the Curve (AUC)(0-t)	AUC(0-t), which is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).	12 hours post-dose	No
Primary	AUC (0-8)	AUC (0-8), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.	12 hours post-dose	No
Secondary	AUC(10 min)	AUC(10 min) which is the area under the plasma concentration verses time curve from start of drug administration until 10 minutes	10 minutes post-dose	No