Nicotine Pharmacokinetics
Conditions
Interventions
A:ENDS1 10 puffs,1puff every 30s
B:ENDS2 10 puffs,1puff every 30s
C:ENDS3 10 puffs,1puff every 30s
D:conventional cigarettes,10 puffs, 1puff every 30s
E:puff ENDS1 ad libitum for 5mins
F:puff ENDS2 ad libitum for 5mins
G:puff ENDS2 ad libitum for 5mins
H:puff conventional cigarettes ad libitum for 5mins
I:use nicotine gum for 30 mins
Sponsors
Dongguan Kanghua Hospital Phase I Clinical Trial Research Center
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy male or female subjects; 2. The subjects fully understand the purpose, nature, process, and potential adverse reactions of the experiment, voluntarily act as subjects, and sign an informed consent form before all research procedures begin; 3. The age at the time of signing the informed consent form is 18 years old or above and 45 years old or below (including 18 years old and 45 years old); 4. Men should weigh at least 50.0 kg, while women should weigh at least 45.0 kg; The body mass index (BMI) of all subjects ranges from 19.0 to 26.0 kg/m2 (including boundary values); 5. When screening, the exhaled carbon monoxide (CO) content is>=10 ppm; 6. Urine cotinine test was positive at screening and enrollment; 7. Screening and asking participants to self report that they smoke an average of at least 10 cigarettes per day, ranging in length from 83 mm to 100 mm, and have a smoking history of at least 6 months before screening; 8. Able to read and fill out questionnaires written in Chinese; 9. Able to communicate well with researchers, understand and comply with the requirements of this study, and be able to complete the study in accordance with the research protocol.
Exclusion criteria
Exclusion criteria: 1. Individuals who are allergic to any component (such as benzoic acid, propylene glycol, glycerol, etc.) in electronic cigarettes or cigarette liquids (aerosols); 2. Smoking habits: Inhaling smoke into the mouth or throat without inhaling smoke into the lungs; 3. Have used nicotine containing products other than cigarettes within the first month of screening; 4. Those who have a smoking cessation plan and have decided to postpone smoking cessation in order to participate in this study; 5. Currently using systemic, estrogen containing contraception, or hormones; 6. Patients with diabetes, asthma or chronic obstructive pulmonary disease; 7. Those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that affects the absorption, distribution, metabolism, and excretion of biomarkers; 8. Diseases with abnormal clinical manifestations that need to be excluded, including but not limited to neurological, cardiovascular, blood and lymphatic systems, immune systems, kidneys, liver, gastrointestinal, respiratory, metabolic, psychiatric, and skeletal system diseases; 9. Those with abnormal vital signs and clinical significance; 10. Patients with poor vascular puncture conditions or inability to tolerate venous puncture, and those with a history of needle and blood fainting; 11. Screening for individuals who have a history of drug abuse (including the use of various narcotic drugs and psychotropic substances in non medical destinations) or have used drugs within the first three months; 12. Those who have participated in other clinical studies (defined as using clinical research drugs) or who have not participated in clinical studies themselves within the first 3 months of screening; 13. Those who donate blood within the first 3 months of screening, including component blood or a large amount of blood loss (>=400 mL), receive blood transfusions or use blood products; 14. All fertile subjects (including male subject partners) have a fertility plan and are unwilling to take appropriate and effective contraceptive measures, or have plans to donate sperm or eggs, from the time they signed the agreement to the last 3 months after using the study product; 15. Use products known to interact with cytochrome P450 (CYP) 2A6 within 14 days prior to screening (including but not limited to amiodarone, amlodipine, aminobarbital, buprenorphine, clofibrate, clotrozole, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, ketoconazole, methanesulfonamide, mezalin, letrozole, mepyrone, miconazole, modafinil, Ofenajun, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyfen, quinidine, rifampicin, rifampicin, scobarbital) Selegilin, sulconazole, thiaconazole, trans cyclopropamide); 16. Those who have used any anticoagulants within the first month of screening (such as clopidogrel, warfarin, or aspirin [>325 mg/day]); 17. Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ˜ 360 mL of beer with 5% alcohol content, 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content) within the first 3 months of screening, or who cannot abstain from alcohol during the study period; 18. Those who consume excessive amounts of tea, coffee, and/or caffeinated beverages (8 or more cups, 1 cup=250 mL) every day within the first 3 months of screening; 19. Those who have consumed pitaya, mango, gr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nicotine;Cmax;AUC;Tmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cotinine;3OH-Cotinine;VAS for urge-to-smoke;mPES; | — |
Countries
China
Contacts
Public ContactGuoping Zhong
Outcome results
None listed