CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
A +4 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04891406
NCT04891406N/ACompleted

A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products (Traditional Snus, Conventional Cigarette and Three Oral Tobacco-free Nicotine Delivery Products)

Imperial Brands PLC·interventional·Posted May 18, 2021·Updated Oct 13, 2023

In Brief

A clinical study evaluating A, B, and 3 other interventions for Healthy Volunteers. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 18, 2021
Enrollment StartJul 1, 2020
Primary CompletionJan 20, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.1 years ago

Interventions

Aother

Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes

Bother

Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes

Cother

Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes

Dother

Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes

Eother

Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes