Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

McNeil-PPC

Status and phase: Completed; Phase 1

Conditions: Tobacco Dependence

Treatments: Drug: Nicotine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01321931

2010-023026-20 (EudraCT Number)

NICTDP1081

Details and patient eligibility

About

Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A study in healthy smokers.

Full description

Fifty (50) healthy male or female subjects between the ages of 19 and 50 years, inclusive, smoking at least 20 cigarettes daily during at least one year preceding inclusion. Multiple doses of all study treatments are given either every 60 minutes or every 90 minutes, respectively. All products will be administered in accordance with labeling, on five separate treatment visits. The subjects will abstain from smoking from 8 pm in the evening before and until the end of each visit.

Enrollment: 50 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy subjects, smoking at least 20 cigarettes daily during at least one year preceding inclusion.
• BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.
• 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.
• Willing and able to comply with all scheduled visits and study procedures

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.
• Any medical condition or history that might, per protocol or in the opinion of the investigator, compromise subject safety or trial results.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 5 patient groups

NRT 60

Experimental group

Description:

A 6 mg dose of an experimental Nicotine Replacement Therapy (NRT) given every hour for 11 hours, with a 36-hour washout between visits

Treatment:

Drug: Nicotine

Drug: Nicotine

Drug: Nicotine

NFG 60

Active Comparator group

Description:

A 4 mg dose of a marketed Nicotine Fruit Gum (NFG) given every hour for 11 hours, with a 36-hour washout between visits

Treatment:

Drug: Nicotine

Drug: Nicotine

Drug: Nicotine

NRT 90

Experimental group

Description:

A 6 mg dose of NRT given every 90 minutes for 10.5 hours, with a 36-hour washout between visits

Treatment:

Drug: Nicotine

Drug: Nicotine

Drug: Nicotine

NFG 90

Active Comparator group

Description:

A 4 mg dose of NFG given every 90 minutes for 10.5 hours, with a 36-hour washout between visits

Treatment:

Drug: Nicotine

Drug: Nicotine

Drug: Nicotine

NIQ 60

Active Comparator group

Description:

A 4 mg dose of marketed nicotine mint lozenge (NIQ), given every hour for 11 hours, with a 36-hour washout between visits

Treatment:

Drug: Nicotine

Drug: Nicotine

Drug: Nicotine