Status:
COMPLETED
Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers
Lead Sponsor:
Philip Morris Products S.A.
Conditions:
Smoking
Nicotine
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
This is a single-center, randomized, controlled, open-label, cross-over study in healthy smoking subjects to investigate the nicotine pharmacokinetic (PK) profiles of 4 variants of Nicotine pouch 1.0 ...
Detailed Description
Study Title: Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers Who carried out the research? This resea...
Eligibility Criteria
Inclusion
- Main
- Subject has smoked continuously for at least the last 3 years prior to the Screening visit.
- Subject has smoked ≥ 10 commercially available cigarettes per day for 4 weeks prior to Screening Visit and Admission. Smoking status will be verified based on a urinary cotinine test (cotinine ≥ 500 ng/mL).
- Subject does not plan to quit using tobacco and/or nicotine products within the next 3 months.
- Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.
- Main
Exclusion
- As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical.
- Subject is legally incompetent, or physically or mentally incapable of giving consent.
- Subject has a clinically relevant disease that requires medication, which as per the judgment of the Investigator would jeopardize the safety of the subject.
- Subject has donated or received whole blood or blood products within 30 days prior to Screening Visit.
- Subject has a BMI \< 18.5 kg/m2 or \> 32.0 kg/m2 (Europe) or \> 35.0 kg/m2 (USA).
- For women only: subject is pregnant (does not have negative pregnancy test at Screening Visit and at Admission) or is breastfeeding.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05317195
Start Date
March 15 2022
End Date
August 18 2022
Last Update
September 27 2024
Active Locations (1)
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1
Celerion
Belfast, Northern Ireland, United Kingdom, BT9 6AD