Nicotine Lozenge Bioequivalence Study

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536704
• Other study ID #: S6491365
• Status: Completed
• Phase: Phase 1
• First received: December 15, 2011
• Last updated: March 14, 2013
• Start date: July 2011
• Est. completion date: August 2011

Study information

• Verified date: March 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nicotine (2 mg)
2 mg nicotine lozenge in two formulations
• Nicotine (4 mg)
4 mg nicotine lozenge in two formulations

Locations

Country	Name	City	State
United States	Celerion NEBRASKA	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No