Trial Outcomes & Findings for Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab (NCT NCT01238640)

Results Overview

Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

During 10 hours post-dose

Results posted on

2012-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Overall Study
Overall Study STARTED	84
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=84 Participants
Age Continuous	32.2 years STANDARD_DEVIATION 9.32 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Region of Enrollment Sweden	84 participants n=5 Participants

PRIMARY outcome

Timeframe: During 10 hours post-dose

Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)

Outcome measures

Outcome measures
Measure	STD 2 mg n=81 Participants An experimental 2 mg nicotine product coded "STD"	STE 2 mg n=82 Participants An experimental 2 mg nicotine product coded "STE"	Nicorette Microtab 2 mg n=82 Participants A comparative 2 mg marketed nicotine product called Nicorette Microtab
Maximum Observed Plasma Concentration (Cmax)	3.90 ng/mL Standard Deviation 1.35	4.00 ng/mL Standard Deviation 1.37	4.08 ng/mL Standard Deviation 1.48

PRIMARY outcome

Timeframe: During 10 hours post-dose

Bioavailability within the Set Period \[AUC(0-t)\] is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour \* nanograms (ng) per milliliter (mL).

Outcome measures

Outcome measures
Measure	STD 2 mg n=80 Participants An experimental 2 mg nicotine product coded "STD"	STE 2 mg n=82 Participants An experimental 2 mg nicotine product coded "STE"	Nicorette Microtab 2 mg n=82 Participants A comparative 2 mg marketed nicotine product called Nicorette Microtab
Area Under the Curve [AUC(0-t)]	12.69 hr*ng/mL Standard Deviation 5.46	12.56 hr*ng/mL Standard Deviation 5.36	13.01 hr*ng/mL Standard Deviation 5.80

PRIMARY outcome

Timeframe: 10 hours post-dose

AUC (0-∞) is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. It is obtained from calculating AUC (0-t) plus AUC (t-∞).

Outcome measures

Outcome measures
Measure	STD 2 mg n=80 Participants An experimental 2 mg nicotine product coded "STD"	STE 2 mg n=82 Participants An experimental 2 mg nicotine product coded "STE"	Nicorette Microtab 2 mg n=82 Participants A comparative 2 mg marketed nicotine product called Nicorette Microtab
AUC(0-∞)	15.74 hr*ng/mL Standard Deviation 6.33	15.09 hr*ng/mL Standard Deviation 6.62	15.57 hr*ng/mL Standard Deviation 7.09

SECONDARY outcome

Timeframe: During 10 hours post-dose

Product Dissolution Time is the time from administration until the investigational products were completely dissolved.

Outcome measures

Outcome measures
Measure	STD 2 mg n=82 Participants An experimental 2 mg nicotine product coded "STD"	STE 2 mg n=83 Participants An experimental 2 mg nicotine product coded "STE"	Nicorette Microtab 2 mg n=82 Participants A comparative 2 mg marketed nicotine product called Nicorette Microtab
Product Dissolution Time	23.3 Minutes Standard Deviation 8.90	23.8 Minutes Standard Deviation 10.22	25.0 Minutes Standard Deviation 6.33

Adverse Events

STD 2 mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

STE 2 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Nicorette Microtab 2 mg

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	STD 2 mg n=84 participants at risk An experimental 2 mg nicotine product coded "STD"	STE 2 mg n=84 participants at risk An experimental 2 mg nicotine product coded "STE"	Nicorette Microtab 2 mg n=84 participants at risk A comparative 2 mg marketed nicotine product called Nicorette Microtab
Gastrointestinal disorders Nausea	4.8% 4/84	3.6% 3/84	10.7% 9/84
Infections and infestations Nasopharyngitis	7.1% 6/84	4.8% 4/84	6.0% 5/84
Nervous system disorders Headache	1.2% 1/84	6.0% 5/84	6.0% 5/84

Additional Information

Joyce Hauze, RPS Sr. Specialist, Clinical Research Operations

Johnson & Johnson Consumer and Personal Products Worldwide

Phone: 928-277-0715

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place