Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Smoking Cessation

Treatments: Drug: Nicotine (4 mg); Drug: Nicotine (2 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01847443

RH01705

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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84 participants in 4 patient groups

Test nicotine gum (2 mg)

Experimental group

Description:

A single dose of Nicotine Mint Gum (2 mg) to be chewed.

Treatment:

Drug: Nicotine (2 mg)

Test nicotine gum (4 mg)

Experimental group

Description:

A single dose of Nicotine Mint Gum (4 mg) to be chewed.

Treatment:

Drug: Nicotine (4 mg)

Reference nicotine gum (2 mg)

Active Comparator group

Description:

A single dose of reference nicotine gum (2 mg) to be chewed.

Treatment:

Drug: Nicotine (2 mg)

Reference nicotine gum (4 mg)

Active Comparator group

Description:

A single dose of reference nicotine gum (4 mg) to be chewed.

Treatment:

Drug: Nicotine (4 mg)