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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: October 11, 2012
Last verified: September 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • AUC0-t [ Time Frame: Day 1, Day 4, Day 7 and Day 10 ] [ Designated as safety issue: No ]
    To compare the AUC0-t of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge

  • Cmax [ Time Frame: Day 1, Day 4, Day 7 and Day 10 ] [ Designated as safety issue: No ]
    To compare the Cmax of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge


Secondary Outcome Measures:
  • AUC0-inf [ Time Frame: Day 1, Day 4, Day 7 and Day 10 ] [ Designated as safety issue: No ]
    To compare the AUC0-inf of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge.

  • tmax [ Time Frame: Day 1, Day 4, Day 7, Day 10 ] [ Designated as safety issue: No ]
    To compare the tmax of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge.

  • Kel [ Time Frame: Day 1, Day 4, Day 7, Day 10 ] [ Designated as safety issue: No ]
    To compare the Kel of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge.

  • t1/2 [ Time Frame: Day 1, Day 4, Day 7, Day 10 ] [ Designated as safety issue: No ]
    To compare the t1/2 of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge.


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
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: October 11, 2012
Health Authority: India: Drugs Controller General of India (DCGI)

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

ClinicalTrials.gov processed this record on May 16, 2013