Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

Johnson & Johnson (J&J)

Status: Completed

Conditions: Tobacco Dependence

Treatments: Drug: Nicotine; Drug: Nicotine Gum

Study type: Interventional

Funder types: Industry

Identifiers

NCT01228617

A6431114-NICTDP1063

Details and patient eligibility

About

This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.

Full description

This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits.

Enrollment: 40 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
• Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
• A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion criteria

• Pregnancy, lactation or intended pregnancy.
• Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 7 patient groups

A1 Short, no buffer

Experimental group

Description:

Nicotine / not yet marketed

Treatment:

Drug: Nicotine

A2 Short, low buffer

Experimental group

Description:

Nicotine / not yet marketed

Treatment:

Drug: Nicotine

A3 Short, high buffer

Experimental group

Description:

Nicotine / not yet marketed

Treatment:

Drug: Nicotine

B1 Long, no buffer

Experimental group

Description:

Nicotine / not yet marketed

Treatment:

Drug: Nicotine

B2 Long, low buffer

Experimental group

Description:

Nicotine / not yet marketed

Treatment:

Drug: Nicotine

B3 Long, high buffer

Experimental group

Description:

Nicotine / not yet marketed

Treatment:

Drug: Nicotine

R = Nicotine Gum

Active Comparator group

Description:

Nicorette® Gum

Treatment:

Drug: Nicotine Gum