Clinical trials: Healthy Smokers
Tobacco Use Disorder
A Bioequivalence Study of 21 Milligram (mg) Nicotine Transdermal Patches (NicoDerm CQ, GlaxoSmithKline [GSK] Dungarvan) Compared to the Current Marketed 21 mg Nicotine Transdermal Patches (NicoDerm CQ, Alza) in Healthy Adult Smokers
The purpose of this study is to assess the bioequivalence of the 21mg nicotine transdermal patch from GSK Dungarvan (Test) compared to the 21mg nicotine transdermal patch currently manufactured by Alza (Reference).
- Trial name
- NCT05024747
- Testing
- NicoDerm CQ patch (GSK Dungarvan), NicoDerm CQ (Alza)
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- HALEON
Nicotine Dependence, Nicotine Dependence, Cigarettes
Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.
A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in Healthy Adult Smokers
- Conditions
- Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use, Tobacco Smoking
- Trial name
- NCT03700112
- Testing
- JUUL Virginia Tobacco flavored 5.0% ENDS, PMI iQOS Heat sticks, Reynolds VUSE Solo ENDS - Original
- Where
- New Zealand
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Juul Labs, Inc.
Smoking Cessation
Comparison of Pharmacokinetic Profiles of 3 New Nicotine Gum Formulations With a Reference Gum
The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess bioequivalence between three new nicotine gum formulations and a reference nicotine gum in healthy smokers.
- Trial name
- NCT02356913
- Testing
- Nicotine gum
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Fertin Pharma A/S
Healthy Smokers
Nicotine Patch - Bioequivalence Study
The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine patch to that of a reference formulation following repeated applications
- Trial name
- NCT02089308
- Testing
- Test treatment : V0116 transdermal patch, Reference treatment : Nicotine transdermal patch
- Where
- France
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
Chronic Obstructive Pulmonary Disease (COPD)
Effect of Steroids on Gene Expression in the Healthy Smokers Lungs
Cigarette smoking is the main risk factor for chronic obstructive pulmonary disease (COPD). The cells lining the lung airways (epithelium) and the cells on the surface of the epithelium (alveolar macrophages) of healthy smokers…
- Trial name
- NCT00532584
- Testing
- Beclomethasone
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
Chronic Obstructive Pulmonary Disease
Systemic Endothelial Abnormalities in COPD
The purpose of this project is to validate the peripheral arterial pressure waveform measurements technique of RAAP (radial artery applanation tonometry), in patients with moderate and severe COPD (Chronic Obstructive Pulmonary…
- Trial name
- NCT00555529
- Testing
- radial artery applanation tonometry (RAAP)
- Where
- 2 sites in United Kingdom
- Volunteers
- healthy volunteers welcome
- Sponsor
- Imperial College London
Nicotine Dependence, Nicotine Dependence, Cigarettes
United States Pre-Market Tobacco Application Pharmacokinetics
A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures with Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combustible Cigarettes, a Comparator…
- Conditions
- Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use, Tobacco Smoking
- Trial name
- US-PMTA-PK (NCT03719391)
- Testing
- Virginia Tobacco flavored JUUL 5% ENDS, Cool Mint flavored JUUL 5% ENDS, Mango flavored JUUL 5% ENDS
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Juul Labs, Inc.
Healthy, Smoking, Cigarette
Investigation of Secreted Phosphoproteins and PiP3 (Phosphoinositolphospat 3) in Sputum
The aim of this study is to validate two new biomarkers in sputum samples. These are PiP3 (phosphoinositolphospat ) and phosphor proteins, representing important proteins within inflammatory situations of the lung.
- Trial name
- NCT03076086
- Testing
- Induced sputum procedure
- Where
- Germany
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
Smoking Cessation
Single-Dose Bioequivalence Study Comparing Two 4 mg Nicotine Lozenges
The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess bioequivalence between a new nicotine lozenge and a reference nicotine lozenge in healthy smokers
- Trial name
- NCT03432312
- Testing
- Nicotine lozenge
- Where
- South Africa
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Fertin Pharma A/S
Pulmonary Disease, Chronic Obstructive
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2256294 in Healthy Volunteers, and Single and Repeat Doses of GSK2256294 in Adult Male Moderately Obese Smokers
This study is the First Time in Human Study for GSK2256294 and will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat oral doses of GSK2256294 administered to healthy male…
- Trial name
- NCT01762774
- Testing
- GSK2256294
- Where
- United Kingdom
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Lifetime Non-smokers
Evaluation of Acute and Subacute Effects of Nicotine Free Electronic Cigarette(NCFE) Vapors
This aim will examine the acute and subacute exposures to electronic cigarette (EC) vapor generated from e-liquids without nicotine (NFEC) on life-time non smokers subjects by measuring changes in nasal ion transport and TGF-β…
- Trial name
- NCT02585791
- Testing
- Propylene Glycol, vegetable glycerin, PG+VG
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Miami
Healthy Volunteers, Smoking
A Nicotine Pharmacokinetics and Smoking Behaviour Study Examining Cigarette Ingredients
This study will compare nicotine delivery and smoking behaviour in healthy subjects using several combustible cigarette prototypes containing different ingredients which are commonly used in the European Union.
- Trial name
- NCT03272295
- Testing
- Reference cigarette, Cigarette with carob bean extract, Cigarette with cocoa powder
- Where
- United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- British American Tobacco (Investments) Limited
Smoking, Healthy Volenteers
Evaluation of GCF MMP-1, -8 and Growth Factor Levels in Smokers With Periodontal Health
Increased levels of cytokines in GCF have been demonstrated in smoker subjects with chronic periodontitis. It is not surprising that increased levels of inflammation associated molecules in GCF has been observed in smokers with…
- Trial name
- NCT02014857
- Testing
- Gingival Crevicular Fluid Sampling
- Where
- Turkey (Türkiye)
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ege University
Asthma, COPD
ATP/AMP Challenge in Healthy Non-smokers, Smokers, Patients With Asthma, and Patients With Chronic Obstructive Pulmonary Disease (COPD)
In this randomised, cross-over, controlled study, a total of 84 subjects will be included: 12 healthy non-smoking volunteers; 12 current smokers; 30 patients with mild steroid-naïve asthma; and 30 patients with mild-moderate…
- Conditions
- Asthma, COPD, Smoking
- Trial name
- NCT00159315
- Testing
- Inhalation Challenge with ATP, Inhalation Challenge with AMP
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Tobacco Dependence
Clinical Study to Assess Bioequivalence Between Nicorette Extra Mint Gum and Nicorette® Mint Gum in Healthy Smokers
This is a research study to verify the same effectiveness and safety profile for the test products, nicotine 2 mg gum and nicotine 4 mg gum, as for the already approved products, Nicorette Mint 2 mg gum and Nicorette Mint 4 mg…
- Trial name
- NCT03259607
- Testing
- Nicorette Extra Mint 2 mg Gum, Nicorette Mint 2 mg Gum, Nicorette Extra Mint 4mg Gum
- Where
- China
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- McNeil AB
Healthy Volunteer Smokers
A Single Dose Bioequivalence Study OfTwo Formulations Of Nicotine Lozenges
Open label, single dose, four-way crossover in healthy smokers. Each subject will be treated with a single dose or four study treatments in a randomized sequence.
- Trial name
- NCT00651352
- Testing
- 4 mg nicotine lozenge, 2 mg nicotine lozenge, 2 mg nicotine prototype
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers, Moderate to Heavy Smokers
Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects
Open label study of Pracinostat will be tested to assess the effect of food on the single-dose pharmacokinetics in healthy non-smoking and smoking adult subjects under fasted and fed conditions.
- Conditions
- Healthy Volunteers, Moderate to Heavy Smokers, Non-smokers
- Trial name
- HVFE (NCT02058784)
- Testing
- pracinostat
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Helsinn Healthcare SA
Healthy Volunteers, Non-smokers
Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects
This study is designed as a 2-part, open-label study to assess the effect of pracinostat with itraconazole (part 1) and pracinostat with ciprofloxacin (part 2) on the bioavailability of pracinostat.
- Trial name
- NCT02118909
- Testing
- Pracinostat, Itraconazole, Ciprofloxacin
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Helsinn Healthcare SA
Healthy Smokers
Nicotine Patch - Multidose Bioequivalence Study
The purpose of this study is to compare the relative bioavailability of nicotine following repeated applications of a new transdermal formulation to that of a reference formulation. Up to day 7
- Trial name
- NCT01658215
- Testing
- V0116 transdermal patch (Test treatment ), Nicotine transdermal patch (Reference treatment )
- Where
- France
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
Smoking, Vaccines
A Study to Assess the Safety and Tolerability of Different Doses of PF-05402536 and PF-06413367 in Healthy Adult Smokers.
The purpose of this study is to determine the safety and tolerability of multiple doses of PF-05402536 and PF-06413367 in healthy adult smokers.
- Trial name
- NCT01672645
- Testing
- NIC7-001, NIC7-003, Saline
- Where
- 3 sites in Canada
- Volunteers
- 277 people, healthy volunteers welcome
- Sponsor
- Pfizer