Pharmacokinetic Study of 4 mg Nicotine Lozenge.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Smoking Cessation

Treatments: Drug: nicotine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01669122

RH01333

Details and patient eligibility

About

This is a randomized, single center, open label, single dose, four way crossover study in fasted healthy male subjects to compare the pharmacokinetics of nicotine following administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge. Blood samples will be drawn at pre-specified intervals for a total of 12 hours post dose in each treatment session and plasma samples analyzed for nicotine levels.

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• smoked commercially-manufactured cigarettes daily for the preceding 12 months and routinely smokes first cigarette within 30mins of awakening.

Exclusion criteria

• inability to refrain from smoking during confinement period, smoking tobacco in any other form other than commercially manufactured cigarettes, subject has used chewing tobacco or other tobacco products other than commercially manufactured cigarettes within 7 days of dosing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Prototype 1

Experimental group

Description:

4mg nicotine lozenge administered orally as a single dose treatment per subject

Treatment:

Drug: nicotine

Prototype 2

Experimental group

Description:

4mg nicotine lozenge administered orally as a single dose treatment per subject

Treatment:

Drug: nicotine

Prototype 3

Experimental group

Description:

4mg nicotine lozenge administered orally as a single dose treatment per subject

Treatment:

Drug: nicotine

Reference Therapy

Active Comparator group

Description:

4mg nicotine lozenge (internationally marketed) to be administered orally as a single dose treatment per subject.

Treatment:

Drug: nicotine