Status:
COMPLETED
Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P
Lead Sponsor:
Philip Morris Products S.A.
Conditions:
Pharmacokinetics
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
This is a single-center, open-label, randomized, crossover study to evaluate the pharmacokinetic (PK) profiles of four P3P variants (differing in nicotine aerosol particle size, nicotine concentration...
Detailed Description
The goal of the proposed study is to evaluate the pharmacokinetic profiles of four P3P variants. Variants with two different nicotine contents (1 mg/product and 2 mg/product), two different nicotine a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subject has signed the Informed Consent Form (ICF) and is able to understand the information provided in the ICF.
- Subject is between 21 and 65 years old.
- Subject is Caucasian.
- Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the screening period.
- Subject has been smoking at least 10 commercially available cigarettes per day at least for the last 4 weeks prior to Screening Visit. Smoking status will be verified based on a urinary cotinine test (cotinine ≥ 200 ng/mL).
- Subject has been smoking for at least the last 3 years prior to Screening Visit.
- Subject does not plan to quit smoking in the next 2 months after the Screening Visit.
- Exclusion criteria:
- Female subject is pregnant or breastfeeding.
- Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy.
Exclusion
Key Trial Info
Start Date :
November 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2018
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03369340
Start Date
November 7 2017
End Date
May 2 2018
Last Update
January 31 2020
Active Locations (1)
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1
CROSS Research
Arzo, Canton Ticino, Switzerland, 6864