Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

Smoking Cessation Clinical Trial

Official title:

A Pharmacokinetic Study Comparing Two Nicotine Gum Formulations in a Single Dose Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847443
• Other study ID #: RH01705
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2013
• Last updated: March 6, 2014
• Start date: May 2013
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy smokers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• BMI within the range of 19 to 30 kilograms/meters^2

• Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up

Exclusion Criteria:

• Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids

• Treatment with known hepatic enzyme altering agents

Study Design

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nicotine (2 mg)
2 mg nicotine gum in two formulations
• Nicotine (4 mg)
4 mg nicotine gum in two formulations

Locations

Country	Name	City	State
United Kingdom	Celerion - BELFAST	Belfast	Northern Ireland

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product	AUC(0-t) for 2 mg test was compared with 2 mg reference gum	Blood samples to be collected from baseline to 12 hours post dose	No
Primary	AUC(0-t) of Nicotine 4 mg Test and Reference Product	AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum	Blood samples to be collected from baseline to 12 hours post dose	No
Primary	Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product	Cmax for 2 mg test was compared with 2 mg reference gum	Blood samples to be collected from baseline to 12 hours post dose	No
Primary	Cmax of Nicotine 4 mg Test and Reference Product	Cmax for 4 mg test was compared with 4 mg reference gum	Blood samples to be collected from baseline to 12 hours post-dose	No
Secondary	Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products	Tmax for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum	Blood samples to be collected from baseline to 12 hours post dose	No
Secondary	Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products	T1/2 of 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum	Blood samples to be collected from baseline to 12 hours post dose	No
Secondary	Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products	Kel for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum	Blood samples to be collected from baseline to 12 hours post dose	No
Secondary	Area Under Concentration-time Curve From Time 0 Extrapolated to 8 [AUC(0-8)] of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products	AUC(0-8) for 2mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum	Blood samples to be collected from baseline to 12 hours post dose	No