Pharmacokinetic Study of 4 mg Nicotine Lozenge.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01669122
First received: August 16, 2012
Last updated: July 11, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Smoking Cessation
Drug: nicotine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Cross-Over, Single Dose Pharmacokinetic Study of 4mg Nicotine Lozenges.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Tmax was determined from plasma concentration time profiles. Tmax was based on the baseline adjusted nicotine plasma concentration data.

  • 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 ] [ Designated as safety issue: No ]
    Elimination rate constant for nicotine was calculated. Kel was based on the baseline adjusted nicotine plasma concentration data.

  • 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 ] [ Designated as safety issue: No ]
    Half-life of elimination of nicotine was determined. t1/2 was based on the baseline adjusted nicotine plasma concentration data.


Enrollment: 40
Study Start Date: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669122

Locations
India
Lambda Therapeutic Research Ltd
Ahmedabad, Gujarat, India, 380 061
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01669122     History of Changes
Other Study ID Numbers: RH01333
Study First Received: August 16, 2012
Last Updated: July 11, 2013
Health Authority: India: Drugs Controller General of India (DCGI)

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014