Status:
COMPLETED
A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products
Lead Sponsor:
Imperial Brands PLC
Conditions:
Healthy Volunteers
Eligibility:
All Genders
19-99 years
Phase:
NA
Brief Summary
This study is a randomised cross-over, open-label, confinement study conducted in 24 male or female snus and cigarette consumers. The study investigates 5 different nicotine containing products in a c...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator
- Dual user of snus and conventional cigarettes for ≥1 year, with a minimum weekly consumption of two or more snus cans and \>5 cigarettes, and who is willing and able to use brands with nicotine content ≥1%
Exclusion
- History of any clinically significant disease or disorder
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first use of IP
- Positive for HIV, hepatitis B or C
- After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:
- Systolic blood pressure \<90 or \>140 mmHg, or
- Diastolic blood pressure \<50 or \>90 mmHg, or
- Pulse \<40 or \>90 bpm
- Alcohol or drug abuse
- Use, or history of use of anabolic steroids
- Allergy/hypersensitivity to drugs with a similar chemical structure or class to nicotine
- Excessive caffeine consumption (daily intake of \>5 cups)
- Female subjects who are pregnant or breastfeeding
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04891406
Start Date
July 1 2020
End Date
January 20 2021
Last Update
October 13 2023
Active Locations (1)
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1
CTC Clinical Trial Consultants AB (CTC)
Uppsala, Sweden, SE-752 37