Pharmacokinetic Study of 4 mg Nicotine Lozenge.
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ClinicalTrials.gov Identifier: NCT01669122 |
Recruitment Status
:
Completed
First Posted
: August 20, 2012
Results First Posted
: January 22, 2015
Last Update Posted
: January 22, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking Cessation | Drug: nicotine | Phase 2 |
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 |
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
|
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669122
India | |
Lambda Therapeutic Research Ltd | |
Ahmedabad, Gujarat, India, 380 061 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01669122 History of Changes |
Other Study ID Numbers: |
RH01333 |
First Posted: | August 20, 2012 Key Record Dates |
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 |