A research study to investigate the absorption of nicotine from a number of Tobacco Products and an Over the Counter (OTC) Nicotine Gum

Completed

• Conditions: Pharmacokinetic study with healthy volunteers; Not Applicable

• Registration Number: ISRCTN11703777
• Lead Sponsor: British American Tobacco (Investments) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-29
• Last Update Posted: 2015-01-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Subjects will be males or non-pregnant, non-lactating females between 19 and 55 years of age inclusive. Female subjects must be postmenopausal (absence of menstrual discharge for at least two years and a serum FSH exceeding 30IU/L) or premenopausal/ perimenopausal with effective contraception (oral, injected or implanted contraceptives, intrauterine device or status after operative sterilisation).
2. Subjects must be in good health as determined by
2.1. medical history
2.2. 12-lead Electrocardiogram (ECG)
2.3. vital signs
2.4. physical examination
3. Subjects must have a body mass index (BMI) between 18 and 30 kg/m2 inclusive. Male subjects must have a weight between 50 and 110kg and female subjects between 40 and 90kg.
4. Subjects will have results of clinical laboratory evaluations within normal ranges (or if outside the normal ranges deemed as not clinically significant by the Investigator).
5. Subjects will have negative results for the drug screening test.
6. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
7. Subjects will be occasional smokers of 9-10mg ISO Tar cigarettes (on average, no more than 40 cigarettes per week) and daily snus users, who use snus products under their upper lip. If the subjects are pouched users they must use products of pouch weights 0.8g and above. They must have used snus and cigarettes for a minimum of six months prior to the start of the study.

Exclusion Criteria

1. Subjects who have a history of, or clinically active significant, medical disorders incluing:
1.1. neurological
1.2. gastrointestinal
1.3. renal
1.4. hepatic
1.5. cardiovascular
1.6. psychiatric
1.7. respiratory
1.8. metabolic
1.9. endocrine
1.10. haematological disease
1.11. other major disorders
2. Subjects who have taken prescription or non-prescription drugs in the 14 days prior to the Screening Visit excluding oral contraceptives.
3. Subjects who have used any medication which interferes with the cyclo oxygenase pathway (anti-inflammatory drugs such as aspirin or ibuprofen) in the 14 days prior to the start of the study (Screening visit).
4. Subjects who have received any medications known to chronically alter nicotine absorption or elimination processes within 30 days of the first product administration.
5. Female subjects, who are pregnant or become pregnant during the course of the study.
6. Subjects who have lost or donated (more than 450ml) blood, plasma or platelets within the 3 months preceding the first product administration.
7. Subjects who are participating in another clinical research study.
8. Subjects who are currently trying to stop smoking or considering stopping in the next two months.
9. Subject who are currently trying to stop the use of snus or considering stopping in the next two months.
10. Subjects who in the opinion of the Investigator should not participate in the study.
11. Subjects who were unwilling or unable to abide by the study requirements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified