Nicotine Lozenge Bioequivalence Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01536704

First received: December 15, 2011

Last updated: March 14, 2013

Last verified: March 2013

History of Changes

Results First Received: March 14, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Screening
Condition:	Smoking Cessation
Interventions:	Drug: Nicotine (2 mg) Drug: Nicotine (4 mg)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at the clinical site.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 141 participants screened, only 50 were randomized since 91 were screen failures.

Reporting Groups

	Description
2 Milligram (mg) Cherry Lozenge	Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
2mg Mint Lozenge	Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
4mg Cherry Lozenge	Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
4mg Mint Lozenge	Participants were instructed to move the 4mg Mint mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.

Participant Flow for 7 periods

Period 1: Period 1

	2 Milligram (mg) Cherry Lozenge	2mg Mint Lozenge	4mg Cherry Lozenge	4mg Mint Lozenge
STARTED	12	12	13	13
COMPLETED	12	12	13	13
NOT COMPLETED	0	0	0	0

Period 2: Washout Period 1

	2 Milligram (mg) Cherry Lozenge	2mg Mint Lozenge	4mg Cherry Lozenge	4mg Mint Lozenge
STARTED	12	12	13	13
COMPLETED	11	10	13	13
NOT COMPLETED	1	2	0	0
Withdrawal by Subject	1	2	0	0

Period 3: Period 2

	2 Milligram (mg) Cherry Lozenge	2mg Mint Lozenge	4mg Cherry Lozenge	4mg Mint Lozenge
STARTED	13 ^[1]	11 ^[1]	10 ^[1]	13 ^[1]
COMPLETED	13	11	10	13
NOT COMPLETED	0	0	0	0

[1]	Due to crossover design, a different set of subjects received this treatment compared to Period 1

Period 4: Washout Period 2

	2 Milligram (mg) Cherry Lozenge	2mg Mint Lozenge	4mg Cherry Lozenge	4mg Mint Lozenge
STARTED	13	11	10	13
COMPLETED	12	11	10	12
NOT COMPLETED	1	0	0	1
Adverse Event	1	0	0	0
Withdrawal by Subject	0	0	0	1

Period 5: Period 3

	2 Milligram (mg) Cherry Lozenge	2mg Mint Lozenge	4mg Cherry Lozenge	4mg Mint Lozenge
STARTED	10 ^[1]	12 ^[1]	12 ^[1]	11 ^[1]
COMPLETED	10	12	12	10
NOT COMPLETED	0	0	0	1
Adverse Event	0	0	0	1

[1]	Due to crossover design, a different set of subjects received this treatment compared to Period 2

Period 6: Washout Period 3

	2 Milligram (mg) Cherry Lozenge	2mg Mint Lozenge	4mg Cherry Lozenge	4mg Mint Lozenge
STARTED	10	12	12	10
COMPLETED	10	12	11	10
NOT COMPLETED	0	0	1	0
Adverse Event	0	0	1	0

Period 7: Period 4

	2 Milligram (mg) Cherry Lozenge	2mg Mint Lozenge	4mg Cherry Lozenge	4mg Mint Lozenge
STARTED	12 ^[1]	11 ^[1]	10 ^[1]	10 ^[1]
COMPLETED	12	11	10	10
NOT COMPLETED	0	0	0	0

[1]	Due to crossover design, a different set of subjects received this treatment compared to Period 3

Baseline Characteristics

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Reporting Groups

	Description
All Randomized Participants	All randomized participants were evaluated for baseline measures

Baseline Measures

	All Randomized Participants
Number of Participants [units: participants]	50
Age [units: Years] Mean ± Standard Deviation	30.3 ± 9.58
Gender [units: Participants]
Female	17
Male	33

Outcome Measures

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1. Primary:

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] [ Time Frame: 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 ]

Show Outcome Measure 1

2. Primary:

Maximum Observed Plasma Concentration [Cmaximum (Max)] [ Time Frame: 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 ]

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3. Secondary:

AUC [0-infinity (Inf)] [ Time Frame: 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 ]

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4. Secondary:

Time to Reach Maximum Plasma Nicotine Concentration (Tmax) [ Time Frame: 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 ]

Show Outcome Measure 4

5. Secondary:

Apparent Elimination Half-life of Nicotine T(1/2) [ Time Frame: 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 ]

Show Outcome Measure 5

6. Secondary:

Elimination Rate Constant for Plasma Nicotine: K (el) [ Time Frame: 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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01536704 History of Changes
Other Study ID Numbers:	S6491365
Study First Received:	December 15, 2011
Results First Received:	March 14, 2013
Last Updated:	March 14, 2013
Health Authority:	United States: Food and Drug Administration

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