Pharmacokinetic Study of 4 mg Nicotine Lozenge.

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Drug: nicotine	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized, Cross-Over, Single Dose Pharmacokinetic Study of 4mg Nicotine Lozenges.
Study Start Date :	June 2012
Actual Primary Completion Date :	August 2012
Actual Study Completion Date :	August 2012

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Prototype 1; 4mg nicotine lozenge administered orally as a single dose treatment per subject	Drug: nicotine; 4 mg nicotine lozenge experimental
Experimental: Prototype 2; 4mg nicotine lozenge administered orally as a single dose treatment per subject	Drug: nicotine; 4 mg nicotine lozenge experimental
Experimental: Prototype 3; 4mg nicotine lozenge administered orally as a single dose treatment per subject	Drug: nicotine; 4 mg nicotine lozenge experimental
Active Comparator: Reference Therapy; 4mg nicotine lozenge (internationally marketed) to be administered orally as a single dose treatment per subject.	Drug: nicotine; 4 mg nicotine lozenge experimental

Outcome Measures

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Primary Outcome Measures :

1. Area Under the Curve From Time 0 to t, AUC (0-t) [ Time Frame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing ]
   Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined from plasma concentration time profile of nicotine. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.
2. Maximum Plasma Concentration (Cmax) [ Time Frame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing ]
   Maximum plasma nicotine concentration was determined from plasma-concentration time profiles. Cmax was based on the baseline adjusted nicotine plasma concentration data.

Secondary Outcome Measures :

1. AUC(0-inf) [ Time Frame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing ]
   Area under the plasma nicotine concentration-time curve from zero extrapolated to infinity was determined. AUC(0-inf) was based on the baseline adjusted nicotine plasma concentration data.
2. Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing ]
   Tmax was determined from plasma concentration time profiles. Tmax was based on the baseline adjusted nicotine plasma concentration data.
3. Rate of Elimination (Kel) [ Time Frame: Blood samples were collected pre-dose at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing ]
   Elimination rate constant for nicotine was calculated. Kel was based on the baseline adjusted nicotine plasma concentration data.
4. Plasma Half Life (t1/2) [ Time Frame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing ]
   Half-life of elimination of nicotine was determined. t1/2 was based on the baseline adjusted nicotine plasma concentration data.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Locations

India
Lambda Therapeutic Research Ltd
Ahmedabad, Gujarat, India, 380 061

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01669122 History of Changes
Other Study ID Numbers:	RH01333
First Posted:	August 20, 2012
Results First Posted:	January 22, 2015
Last Update Posted:	January 22, 2015
Last Verified:	October 2014

Additional relevant MeSH terms:

Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs	Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action