Nicotine Lozenge Bioequivalence Study

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

NCT01536704

S6491365

Details and patient eligibility

About

To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.

Enrollment: 50 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must be healthy smokers who usually smoked their first cigarette within 30 minutes of waking.
• Body Mass Index within the range 19-27 kilograms/meters^2

Exclusion criteria

• Participants who used chewing tobacco or tobacco products other than cigarettes within 21 days of screening visit

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

Test nicotine lozenge (2 mg)

Experimental group

Description:

2 mg test nicotine lozenge to be chewed.

Treatment:

Drug: Nicotine (2 mg)

Test nicotine lozenge (4 mg)

Experimental group

Description:

4 mg test nicotine lozenge to be chewed.

Treatment:

Drug: Nicotine (4 mg)

Reference nicotine lozenge (2 mg)

Active Comparator group

Description:

2 mg reference nicotine lozenge to be chewed.

Treatment:

Drug: Nicotine (2 mg)

Reference nicotine lozenge (4 mg)

Active Comparator group

Description:

4 mg reference nicotine lozenge to be chewed.

Treatment:

Drug: Nicotine (4 mg)