NCT01536704 - Nicotine Lozenge Bioequivalence Study | Crick | Crick

Nicotine Lozenge Bioequivalence Study

Phase 1CompletedNCT01536704

GlaxoSmithKline50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

50

Conditions

Smoking Cessation

Interventions

Nicotine (2 mg)DRUG

2 mg nicotine lozenge in two formulations

Nicotine (4 mg)DRUG

4 mg nicotine lozenge in two formulations

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Celerion NEBRASKA

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]

AUC(0-t) was evaluated using the trapezoid rule.

Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Maximum Observed Plasma Concentration [Cmaximum (Max)]

Cmax was depicted from plasma concentration of nicotine.

Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Secondary Outcomes

AUC [0-infinity (Inf)]

AUC (0-inf) was evaluated using the trapezoid rule.

Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Time to Reach Maximum Plasma Nicotine Concentration (Tmax)

Tmax was time at which Cmax of nicotine was reached.

Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Apparent Elimination Half-life of Nicotine T(1/2)

T(1/2) was calculated using plasma time-concentration values.

Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Elimination Rate Constant for Plasma Nicotine: K (el)

Kel was calculated with the help of plasma time concentration values.

Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Data from ClinicalTrials.gov

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