N/A
N=24
A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT04891406 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Nicotine Cmax — 5.154; 7.856; 9.553; 12.51 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- A (Other); B (Other); C (Other); D (Other); E (Other)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Imperial Brands PLC
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nicotine Cmax |
5.154; 7.856; 9.553; 12.51; 11.60 | — |
| PRIMARY Nicotine AUCt |
12.23; 18.35; 21.13; 31.31; 19.60 | — |
| SECONDARY Nicotine Extraction |
13.47; 14.31; 12.56; 18.61 | — |
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 cross-over fashion. The study incorporates pharmacokinetics evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety evaluation.
During the study participation, subjects come for two visits to the clinic, including a 5-day confinement period.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 140 mmHg, or
- Diastolic blood pressure 90 mmHg, or
- Pulse 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
Data sourced from ClinicalTrials.gov (NCT04891406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.