Nicotine Lozenge Bioequivalence Study

A Single Dose Bioequivalence Study of 2 Different Doses of Mini Cherry Nicotine Lozenges

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 Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Nicotine (2 mg); Drug: Nicotine (4 mg)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion NEBRASKA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test nicotine lozenge (2 mg); 2 mg test nicotine lozenge to be chewed.	Drug: Nicotine (2 mg); 2 mg nicotine lozenge in two formulations
Experimental: Test nicotine lozenge (4 mg); 4 mg test nicotine lozenge to be chewed.	Drug: Nicotine (4 mg); 4 mg nicotine lozenge in two formulations
Active Comparator: Reference nicotine lozenge (2 mg); 2 mg reference nicotine lozenge to be chewed.	Drug: Nicotine (2 mg); 2 mg nicotine lozenge in two formulations
Active Comparator: Reference nicotine lozenge (4 mg); 4 mg reference nicotine lozenge to be chewed.	Drug: Nicotine (4 mg); 4 mg nicotine lozenge in two formulations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC [0-infinity (Inf)]	AUC (0-inf) was evaluated using the trapezoid rule.	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.	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.	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.	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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: February 16, 2012
• First Posted (Estimate): February 22, 2012

Study Record Updates

• Last Update Posted (Estimate): April 26, 2013
• Last Update Submitted That Met QC Criteria: March 14, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: nicotine replacement therapy; nicotine; nicotine lozenge
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: S6491365